About BridgeBio Pharma, Inc. 

BridgeBio is a biopharmaceutical company dedicated to discovering, developing, and delivering transformative medicines for patients living with genetic diseases and genetically defined cancers. Since our founding in 2015, we have built a diverse portfolio of more than 20 drug development programs, ranging from early discovery to late-stage clinical trials, across multiple therapeutic areas including precision oncology, cardiology, endocrinology, neurology, and renal disease. We have already achieved regulatory approval for three therapies and continue to advance promising science from academia into meaningful treatments for patients worldwide. 

Who We Are 

BridgeBio is a global biotechnology company with our Global Headquarters located in San Francisco, USA, and our International HQ located in Zug, Switzerland. Since establishing our European presence in 2021, we’ve been building empowered, high-performing teams across countries — with experienced colleagues who move quickly, take ownership, and are fueling the company’s international growth. 

At BridgeBio, you’ll find an energetic and collaborative culture where pragmatism meets bold decision-making. We embrace uncertainty with confidence, guided by our commitment to making a meaningful impact for patients. Our people are trusted and empowered, united by urgency, purpose, and the drive to advance science for patients around the world. 

To learn more about our story and company culture, visit us at https://bridgebio.com

What You'll Do

The legal work behind bringing medicines to patients is rarely one-dimensional. It spans commercial contracting, launch readiness, promotional review, digital channels, compliance, privacy, and the judgment to know when to move quickly and when to pause.

As Legal Counsel, International, reporting to the VP, Associate General Counsel, Legal International, you will serve as a hands-on legal business partner supporting pre-launch activities, commercial launch, and ongoing operations across Europe. You will advise a broad range of stakeholders, delivering practical, business-oriented guidance, managing risk thoughtfully, and helping the organization move with clarity, consistency, and speed.

This role is suited to a pragmatic lawyer who is excited by breadth, ownership, and the opportunity to help build scalable legal frameworks in a fast-moving biotech environment.

Responsibilities

Commercial Contracting & Day-to-Day Legal Support

• Draft, review, negotiate, and advise on a broad range of agreements, including supplier and vendor agreements, master services agreements, service agreements, NDAs/CDAs, technology and digital services contracts, and other ancillary commercial documents
• Provide day-to-day legal support across Commercial, Medical Affairs, Regulatory, Market Access, Finance and Supply Chain, on contractual and commercial, ensuring alignment with applicable laws, internal policies, and business objectives
• Advice on contract structuring, liability and risk allocation, and contract interpretation, and helping manage the full contracting lifecycle in partnership with business stakeholders

Commercial Launch, Marketing & Promotional Review

• Support launch readiness and ongoing commercial operations across relevant European markets by advising on pre-marketing activities, field force materials, promotional reviews, patient support initiatives and operational readiness questions
• Support EU MLR (Medical, Legal, Regulatory) review for Legal International, ensuring promotional and medical materials meet EU and national requirements, giving clear, enabling advice on claims, fair balance, substantiation, and appropriate risk mitigation
• Support the development and maintenance of EU-specific promotional review guidelines and support training of cross-functional stakeholders on compliant pre-marketing and promotion practices

Operational Excellence & Cross-Functional Partnership

• Partner closely with the global Compliance function to identify, assess, and manage regional compliance risks, including competition law, anti-bribery and anti-corruption, sanctions, and commercial governance, while supporting guidance and oversight on applicable industry codes and ethical standards across Europe
• Champion continuous improvement in legal operations, including the implementation and responsible use of modern legal tools, templates, playbooks, and AI-enabled solutions
• Contribute to legal training, knowledge sharing, and a culture of legal excellence across the wider Legal Department
• Handle additional legal projects and operational matters assigned

Where You'll Work

• This is an office role based and requires in-office collaboration 2-3x per week in our Zug Office
• Domestic and international travel is expected when required

Who You Are

• Swiss or EU qualified lawyer with 4–5 years of post-qualification experience in pharmaceutical or biotech, with meaningful exposure to commercial operations, product launch, and cross-functional legal support — at a law firm, a company, or both
• You have exposure to additional jurisdictions. MLR (Medical, Legal, Regulatory) review experience required
• You communicate with precision and confidence across all levels — whether advising a field team, sitting in an MLR, presenting to affiliate leadership, or escalating a complex matter to senior legal counsel. People always know where you stand and why
• You build real relationships with the teams you support — and those relationships are what make you effective
• You can work in a fast-paced dynamic work environment with efficient prioritization, responsiveness and focus (especially during periods of sustained pressure and often under tight deadlines). You are flexible and have a high tolerance for ambiguity
• You are fluent in English (working proficiency required); proficiency in an additional European language is preferred

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.  

• Market leading compensation 
• Hybrid work model - we value your flexibility in how you work, but encourage time in the office to strengthen our culture, collaboration, and sense of community
• We provide career development through regular feedback, continuous education and professional development programs
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
  
  

About BridgeBio Pharma, Inc. 

BridgeBio is a biopharmaceutical company dedicated to discovering, developing, and delivering transformative medicines for patients living with genetic diseases and genetically defined cancers. Since our founding in 2015, we have built a diverse portfolio of more than 20 drug development programs, ranging from early discovery to late-stage clinical trials, across multiple therapeutic areas including precision oncology, cardiology, endocrinology, neurology, and renal disease. We have already achieved regulatory approval for three therapies and continue to advance promising science from academia into meaningful treatments for patients worldwide. 

Who We Are 

BridgeBio is a global biotechnology company with our Global Headquarters located in San Francisco, USA, and our International HQ located in Zug, Switzerland. Since establishing our European presence in 2021, we’ve been building empowered, high-performing teams across countries — with experienced colleagues who move quickly, take ownership, and are fueling the company’s international growth. 

At BridgeBio, you’ll find an energetic and collaborative culture where pragmatism meets bold decision-making. We embrace uncertainty with confidence, guided by our commitment to making a meaningful impact for patients. Our people are trusted and empowered, united by urgency, purpose, and the drive to advance science for patients around the world. 

To learn more about our story and company culture, visit us at https://bridgebio.com

What You'll Do

In this role, you will report to the VP, Head of Medical Affairs, International and partner closely with the Director, Commercial Excellence, International. You will be responsible for establishing and optimizing Medical Affairs operations and processes, including medical information, while facilitating and coordinating medical planning activities across the organization. You will lead the implementation and continuous improvement of systems such as medical CRM and contribute to excellence in scientific engagement. As a central member of the Medical Affairs organization, you will play a key role in supporting the successful launch of new therapies in rare genetic diseases, working cross-functionally to ensure aligned, efficient, and high-quality execution of medical strategies.

Responsibilities

• Develop and deliver comprehensive onboarding and continuous learning curricula 
• Contribute to annual medical planning across brands 
• Contribute to successful medical launches by building a close partnership with the Commercial Excellence counterpart
• Manage and oversee multiple projects, including medical launch readiness and annual medical planning across brands, to drive consistency and efficiency across the medical organization
• Identify and recommend opportunities for process improvement and innovation in both medical excellence and operations within the Intl Medical Affairs organisation 
• Establish and maintain systems and dashboards as relevant for reporting key execution indicators and outcomes of medical activities
• Collaborate cross-functionally to generate insights and shape strategy using data analytics, demonstrating the value and impact of Medical to the business
• Lead and support core medical processes across brands, including publications and medical congresses and symposia
• Support the management and tracking of the medical budget

Medical Operations & systems  

• Establish and implement medical information processes and systems
• Establish and lead the international Medical, Legal, and Regulatory (MLR) review process in collaboration with Legal and Regulatory teams
• Lead the implementation of a medical CRM, as applicable, for the International Medical organization

The above job description documents the general nature and level of work but is not intended to be an exhaustive list of activities, duties, and responsibilities required of job incumbents. Therefore, job incumbents are expected to perform all other duties as assigned or required, as training and experience allow. 

Where You'll Work

• This is an office role based and requires in-office collaboration 2-3x per week in our Zug Office. No relocation is offered
• Travel (20-30%) may be required to represent the company at medical conferences, key events and meetings 

Who You Are

• Medical degree or Bachelor’s degree in a scientific discipline (advanced degree preferred)
• Extensive experience in the pharmaceutical industry (10+ years), with a solid understanding of drug development and clinical research
• Experience in rare diseases is an advantage
• Excellent verbal and written communication and presentation skills, with experience developing and implementing effective communication and engagement plans
• Strong expertise in systems, platforms, and methodologies, including the generation of associated reports
• Proven experience in establishing and managing medical processes, such as medical information, annual medical planning, and implementation of new systems and innovative ways of working
• Collaborative, team-oriented mindset with the ability to operate effectively in a fast-paced environment
• Demonstrated ability to manage multiple projects and competing priorities with a strong sense of urgency

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.  

• Market leading compensation 
• Hybrid work model - we value your flexibility in how you work, but encourage time in the office to strengthen our culture, collaboration, and sense of community
• We provide career development through regular feedback, continuous education and professional development programs
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
  
  

The Opportunity:

The Executive Director, Head of Quality, Europe is responsible for leading and overseeing all Quality functions across the European region, ensuring compliance with European regulatory requirements. This role provides strategic and operational leadership across GxP Quality (GMP, GDP, GCP as applicable). In addition, this role serves as the key Quality representative for Europe, partnering closely with Regulatory Affairs, Manufacturing, Supply Chain, Clinical Operations, and external partners to ensure a robust and inspection-ready quality system.

Key Responsibilities:

• Lead and develop the European Quality organization, ensuring alignment with global quality strategy and supporting the transition from clinical to commercial operations.

• Act as the primary Quality representative for Europe, providing leadership in regional and global governance forums and serving as the main interface with European regulatory authorities (e.g., EMA, national agencies).

• Ensure Quality oversight of MAH responsibilities, including lifecycle management, product complaints, recalls, and fulfillment of regulatory commitments in close collaboration with Regulatory Affairs.

• Establish, implement, and maintain an effective EU Quality Management System (QMS) in compliance with EU GMP, GDP, GCP (as applicable), and ICH guidelines.

• Participate in cross-functional review of Global SOPs, ensuring timely harmonization and effective implementation within the EMEA region.

• Oversee key quality system processes, including deviations, CAPAs, change control, risk management, product quality complaints, and document management.

• Monitor QMS performance through KPIs, risk indictors and management review process.

• Review quality agreements to ensure compliance with EU GMP, GDP and other regulatory requirements across the supply chain.

• Define and oversee the EU QP framework, ensuring compliant batch certification and appropriate governance of internal and/or contracted QPs.

• Ensure full compliance with EU GDP requirements, including oversight of distribution activities, wholesale authorizations, and Responsible Person (RP) functions within the EU supply network.

• Provide end-to-end Quality oversight of external partners (e.g., CMOs, 3PLs, distributors), including quality agreements, performance monitoring, and risk-based governance.

• Lead inspection readiness across Europe and manage regulatory inspections and internal/external audits, ensuring consistent positioning and effective interaction with authorities.

• Support regulatory submissions and lifecycle activities by ensuring quality oversight of relevant documentation and CMC components.

• Provide Quality leadership for new product introductions, technology transfers, and commercial launches in Europe, ensuring readiness of systems, processes, and partners.

• Collaborate cross-functionally with Regulatory Affairs, Technical Operations, Supply Chain, Clinical Operations, and Global Supplier Quality to ensure integrated and compliant execution across the product lifecycle.

• Drive a strong, proactive quality culture across all European operations, promoting continuous improvement and accountability.

Required Skills, Experience and Education:

• Degree in Life Sciences, Pharmacy, Chemistry, or related field (PhD, PharmD, or MSc preferred).

• 20+ GxP Quality within the pharmaceutical industry.

• Track record of building and scaling Quality organizations.

• Track record of working in a GMP/GDP regulated environment.

• Deep knowledge of European regulatory requirements (EMA, EU GMP/GDP, ICH guidelines).

Preferred Skills:

• Biotech experience.

• Significant leadership experience, including managing regional or global teams.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-Remote #LI-LO1

The Opportunity:

The Executive Director, Head of Quality, Europe is responsible for leading and overseeing all Quality functions across the European region, ensuring compliance with European regulatory requirements. This role provides strategic and operational leadership across GxP Quality (GMP, GDP, GCP as applicable). In addition, this role serves as the key Quality representative for Europe, partnering closely with Regulatory Affairs, Manufacturing, Supply Chain, Clinical Operations, and external partners to ensure a robust and inspection-ready quality system.

Key Responsibilities:

• Lead and develop the European Quality organization, ensuring alignment with global quality strategy and supporting the transition from clinical to commercial operations.

• Act as the primary Quality representative for Europe, providing leadership in regional and global governance forums and serving as the main interface with European regulatory authorities (e.g., EMA, national agencies).

• Ensure Quality oversight of MAH responsibilities, including lifecycle management, product complaints, recalls, and fulfillment of regulatory commitments in close collaboration with Regulatory Affairs.

• Establish, implement, and maintain an effective EU Quality Management System (QMS) in compliance with EU GMP, GDP, GCP (as applicable), and ICH guidelines.

• Participate in cross-functional review of Global SOPs, ensuring timely harmonization and effective implementation within the EMEA region.

• Oversee key quality system processes, including deviations, CAPAs, change control, risk management, product quality complaints, and document management.

• Monitor QMS performance through KPIs, risk indictors and management review process.

• Review quality agreements to ensure compliance with EU GMP, GDP and other regulatory requirements across the supply chain.

• Define and oversee the EU QP framework, ensuring compliant batch certification and appropriate governance of internal and/or contracted QPs.

• Ensure full compliance with EU GDP requirements, including oversight of distribution activities, wholesale authorizations, and Responsible Person (RP) functions within the EU supply network.

• Provide end-to-end Quality oversight of external partners (e.g., CMOs, 3PLs, distributors), including quality agreements, performance monitoring, and risk-based governance.

• Lead inspection readiness across Europe and manage regulatory inspections and internal/external audits, ensuring consistent positioning and effective interaction with authorities.

• Support regulatory submissions and lifecycle activities by ensuring quality oversight of relevant documentation and CMC components.

• Provide Quality leadership for new product introductions, technology transfers, and commercial launches in Europe, ensuring readiness of systems, processes, and partners.

• Collaborate cross-functionally with Regulatory Affairs, Technical Operations, Supply Chain, Clinical Operations, and Global Supplier Quality to ensure integrated and compliant execution across the product lifecycle.

• Drive a strong, proactive quality culture across all European operations, promoting continuous improvement and accountability.

Required Skills, Experience and Education:

• Degree in Life Sciences, Pharmacy, Chemistry, or related field (PhD, PharmD, or MSc preferred).

• 20+ GxP Quality within the pharmaceutical industry.

• Track record of building and scaling Quality organizations.

• Track record of working in a GMP/GDP regulated environment.

• Deep knowledge of European regulatory requirements (EMA, EU GMP/GDP, ICH guidelines).

Preferred Skills:

• Biotech experience.

• Significant leadership experience, including managing regional or global teams.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-Hybrid #LI-LO1

The Opportunity:

Reporting to the VP, GM, Midsized Markets, the Senior Director, Medical Affairs, Midsize Markets Europe, is the medical leader responsible for defining and executing the medical strategy for oncology products in our portfolio within Midsized markets. This role serves as the medical voice within the Midsized markets Leadership Team, ensuring scientific excellence, compliant medical engagement, and strong alignment between global strategy and local patient, physician, and healthcare system needs. This leader will ensure that Midsized markets medical considerations are embedded in the regional medical strategy and plans and will partner with the Midsized markets country managers and crossfunctional teams, as well as VP Head of Europe Medical Affairs and their leadership team. The incumbent will contribute to building the Midsized markets medical team and working closely with the Global, Regional, Country Medical Affairs teams across Med Affairs functions.

Responsibilities:

• Act as the Medical lead for Midsized Markets, accountable for medical strategy, execution, and impact across the RevMed portfolio.

• Serve as a core member of the Midsized Markets Leadership Team, contributing insights to medical and clinical development strategy, launch planning, and business decisions.

• Establish Midsized markets medical strategy across pre-launch, launch, and post-launch phases.

• Oversee all aspects of medical strategy and execution in Midsized markets.

• Cross-functionally align efforts seamlessly with access, regulatory, and commercial objectives while building and executing upon the medical plan.

• Collaborate effectively with regional and global teams by contributing to overall medical strategy, strongly partnering with local, regional and global clinical development and operations teams.

• Translate global medical and clinical strategies into relevant medical strategy.

• Represent the company as the senior medical expert within the local oncology and scientific community, acting as a spokesperson for Midsized markets.

• Gather, analyze and interpret clinical data, providing strategic insights to inform critical decisions.

• Build strong relationships with national key opinion leaders, oncology networks, academic institutions, and scientific societies.

• Lead scientific exchange, advisory boards, investigator and other external meetings, press conferences, and congress engagement at country level.

• Provide medical leadership on evidence generation activities including local studies, real-world evidence initiatives, and investigator-initiated research (where permitted).

• Ensure effective execution of publication plans and scientific communication activities.

• Lead medical launch readiness for oncology products, including training, scientific materials, and field medical engagement plans.

• Partner with Market Access and Commercial country and regional teams to support value communication and reimbursement-related interactions from a medical perspective, e.g. representing and defining evidence and value of innovation at oral HTA hearings.

• Support lifecycle management activities including new indications, label updates, and competitive positioning.

• Provide medical review and approval of non-promotional materials in accordance with local regulations and company policies.

• Help recruit country Medical teams, including Medical Directors and Medical Science Liaisons.

• Establish medical processes, governance, and ways of working as part of the Midsized markets build-out.

• Foster a culture of scientific rigor, compliance, and collaboration.

• Ensure all medical activities comply with local regulations, national and EFPIA codes, and internal company policies.

• Represent Midsized markets Medical Affairs in company governance and risk management forums.

Required Skills, Experience and Education:

• Advanced degree required (MD or PhD).

• Strong background and experience in oncology required.

• 10+ years’ experience in Medical Affairs with a track record of country leadership.

• Experience with scientific data generation, clinical trial interpretation, and communication of complex data to diverse audiences.

• Proven value and benefit assessment experience, with deep understanding of midsized markets access, local healthcare systems and regulatory landscape.

• Strong stakeholder management and ability to collaborate with internal and external partners.

• Proven experience supporting oncology product launches in a European market.

• Experience in biotech.

• Excellent communication skills, both in person and virtual.

• Proven leadership and people management capabilities; demonstrated success in small but fast growing, entrepreneurial environment.

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

• Scientific and solution-orientated mindset and capability to move and execute in a rapidly changing, ambiguous environment.

• Strong understanding of local healthcare systems, customer dynamics, and reimbursement environment.

• Highly organized and motivated individual possessing excellent communication, presentation and interpersonal skills. Thrives in a fast-paced, dynamic small company environment and able to adjust priorities and workload based upon changing needs.

• Willingness to travel nationally and internationally.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-Remote #LI-LO1

Dich erwarten die Übernahme von FvP-Mandaten und sehr vielfältigen Beratungsmandaten international agierender Unternehmen. Als Bestandteil des BakerHicks fvP-Teams, erörterst Du Strategien und Konzepte auf sehr hohem fachlichem Niveau. Du hast die Chance, Dich in einem schnell wachsenden Unternehmen unternehmerisch einzubringen und trägst wesentliche Bestandteile zur Weiterentwicklung und strategischen Ausrichtung von BakerHicks bei. Sehr grosse persönliche Freiheit und Eigenverantwortung bei der Arbeitsgestaltung ist für uns selbstverständlich. Freundlichkeit, Respekt und gegenseitiges Vertrauen prägen unsere Zusammenarbeit.   

Für diese Position suchen wir Bewerbende, die ein Pensum zwischen 20% und 60% suchen.

Deine Aufgaben

• Du unterstützt unser Qualitätsmanagement-Team als "Fachtechnisch verantwortliche Person" (fvP) / Qualified Person (QP) / QA Manager sowie im Bereich Regulatory Affairs, die auf Mandatsbasis für unsere Kunden tätig ist. 
• Zu unseren Kunden zählen Hersteller, Zulassungsinhaber, Grosshändler, Logistiker und Transportunternehmen sowie Firmen mit Handel im Ausland.
• Zu Deiner Aufgaben zählt die Sicherstellung der fachtechnischen Verantwortung gemäss den gesetzlichen Anforderungen nach HMG und AMBV sowie Mitarbeit im Bereich Arzneimittelzulassungen (Regulatory Affairs)

Dein Profil

Du bist eine leistungsstarke, teamfähige und flexible Persönlichkeit mit Durchsetzungsvermögen und einem akademischen Abschluss in Pharmazie, Chemie, Naturwissenschaften etc. Du arbeitest organisiert, strukturiert und genau, um sowohl selbstständig als auch in interdisziplinären Teams die vorgegebenen Ziele zu erreichen. Darüber hinaus erfüllst Du folgende Kriterien:

• Nachgewiesene Zulassung als "Fachtechnisch verantwortliche Person" nach AMBV (bevorzugt Zulassung als fvP auch für Herstellbetriebe)
• GMP-Kenntnisse in der pharmazeutischen Industrie
• Erfahrung mit Arzneimittelzulassung/ Regulatory Affairs von Vorteil
• Lösungsorientiertes Handeln
• Ausgeprägte Kommunikationsfähigkeiten
• Fliessende Sprachkenntnisse in Deutsch und Englisch

Über BakerHicks

Seit 1957 sind wir Vorreiter in den Bereichen Design, Engineering und Projektmanagement. Von der Beratung bis hin zum Bau und der Compliance unterstützen unsere multidisziplinären Design- und Ingenieurteams Unternehmen auf der ganzen Welt dabei, ihre Projekte auf die effizienteste, kostengünstigste und nachhaltigste Weise zu realisieren.

Benefits

• Überstunden voll kompensierbar
• Flexible Arbeitszeiten im Rahmen eines Gleitzeitmodells mit Blockzeiten
• Europäische Projekteinsätze möglich
• Umfassende Spesenregelung zur Aufwandserstattung
• Mitarbeiter werben Mitarbeiter
• 2 verschiedene Pensionskassenlösungen (jährlich wechselbar)
• U-Abo für Pendler
• Flache Hierarchien
• Homeoffice
• Höchster Standard für Arbeitssicherheit
• 25 Urlaubstage
• Volle Lohnzahlung im Krankheitsfall bis zum 30. Tag
• Weltweite Reiseversicherung
• UVG-Zusatzversicherung
• Zuschuss für Velopendler
• Teilzeitarbeit möglich
• Möglichkeit zu unbezahltem Urlaub

Diversität & Inklusion

Bei BakerHicks ist es uns wichtig, dass wir ein Umfeld schaffen, in dem sich alle zugehörig fühlen. Als Unternehmen sind wir in der glücklichen Lage, mit einem vielfältigen Team von Menschen mit den unterschiedlichsten Hintergründen und Erfahrungen zusammenzuarbeiten. Alle von uns sollten respektvolles und positives Verhalten erwarten können, das uns anspornt. Um sicherzustellen, dass wir immer ein offenes Ohr haben und ständig dazulernen, haben wir ein Team zusammengestellt, das uns dabei hilft, unsere Strategien für Diversität und Inklusion zu steuern.

indeed-prio

The Opportunity:

Reporting to the Vice President, General Manager, Mid-Sized Markets of Europe, the Country Manager, Switzerland will lead the expansion efforts critical to maximizing the opportunity for Revolution Medicines (RevMed) innovation to help patients. In collaboration with the regional leadership team, the successful catalytic leader will develop and execute commercial and operational strategy to accelerate the engagement with key stakeholders and customers (government authorities, regulatory authorities, payer authorities, KOLs) in Switzerland as well as all necessary constituencies to support expansion into the European region - ensuring that reimbursement and access considerations are integrated in the existing and future clinical program design of the company portfolio / pipeline. The incumbent will be responsible for developing pre-launch and commercialization strategic plans for Switzerland and providing Swiss-specific input into lifecycle plans across the RevMed portfolio.  This individual will have full accountability for the Switzerland P&L, all Switzerland operations and will ensure official, fiduciary, corporate, legal and compliance requirements are met locally and for the European region respectively. 

Responsibilities:

• Develop and execute comprehensive plans for the company’s expansion in Switzerland.

• Develop and manage the Switzerland P&L including the budget for operations, ensuring optimal resource allocation.

• As dictated by the commercialization strategy, build and lead the required multifunctional management team, working with corporate functional leaders to ensure that each team member and business function execute against the clear and well-aligned business objectives.

• Lead the planning and execution of product launches in Switzerland, including PEL, market access strategies, pricing, medical affairs atrategy, disease area and marketing strategy, and where appropriate, early access programs.

• Lead the Swiss Government/Corporate Affairs efforts ensuring the successful execution of global and European strategies, advocating for policies that promote patient access. Cultivate and maintain strategic relationships with government entities, patient organizations, healthcare providers, industry associations, and medical societies through innovative engagement programs.

• Represent the company in Swiss healthcare policy forums and industry associations, collaborate with peers to shape collective positions and advocate for patient centered policies.

• Evaluate the competitive environment and understand the profile of portfolio compounds and the patients to serve to identify opportunities and challenges in the oncology market across Europe and other key markets.

• Set key launch and financial performance metrics including revenue, profitability etc.

• Provide Switzerland input for Mid-Sized Markets, Regional and Global Clinical Development Plans.

• Support the Clinical Operations team by ensuring appropriate Swiss site selection, quality and enrollment in-line with regulatory/compliance requirements.

• Co-lead with Finance, Legal, and Commercial, the selection and contract negotiation with any local distributor and Trade 3^rd parties and upon completion of contract, oversee and be accountable for successful execution and achievement of goals by the distributor.

• Support the effective negotiation of consultant/agency contracts for timely and cost-effective services in various business areas to support pre-launch and launch activities.

• Foster a culture within the Mid-Sized markets leadership team, regional and global team consistent with the global RevMed values and vision/mission.

• Build, lead, and develop the country organization, including medical, access, sales, marketing, and customer-facing roles as the business scales.

• Establish commercial processes, governance, and ways of working as part of the country build-out.

• Foster a culture of accountability, collaboration, and performance excellence.

• Establish country governance, risk management, and compliance framework and SOPs.

• Ensure all activities comply with local regulations, industry codes, and internal company policies.

Required Skills, Experience and Education:

• Advanced degree in life sciences, business administration, or a related field.

• Minimum 15 years of proven experience in leadership roles within the biopharmaceutical industry in the field of oncology.

• In-depth knowledge of the Swiss pharmaceutical market, access, pricing and regulatory environment.

• Organizational and P&L leadership experience in Switzerland required.

• Proven track record shaping and executing country strategy and influencing policy at a senior industry level.

• Proven experience building and developing a high performing cross-functional team is a must.

• Proven leadership and people management capabilities; demonstrated success in small but fast growing, entrepreneurial commercial environment.

• In depth knowledge of Swissmedic, approval and early access mechanisms of medicinal products in Switzerland.

• Fluency in both verbal and written English and German; French and/or Italian is an advantage.

• Ability to create and nurture a strong culture of collaboration and authenticity to extend and replicate the RevMed culture.

• Proven success in building effective relationships with internal stakeholders, regional authorities, and vendors.

• Highly organized and motivated individual possessing excellent communication, presentation and interpersonal skills.

• Strong leadership and influencing skills with the ability to create a clear sense of direction.

• Thrives in a fast-paced, dynamic small company environment and able to roll out the sleeves to get things done.

Preferred Skills:

• Experience with an oncology launch in Switzerland is desired.

• Serve as business partners to Development and Clinical Operations functions.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-LO1 #LI-Hybrid

The Opportunity:

The Associate Director, Regulatory Operations, Europe will play a key role in supporting the growing European Regulatory Affairs organization by leading the operational planning and execution of regulatory submissions across the region. This role partners closely with the European Regulatory Affairs team to operationalize regional regulatory strategies and ensure successful execution of regulatory submissions to health authorities across the EU, EEA, UK and Switzerland.

Working cross-functionally with regulatory strategy, clinical, CMC, nonclinical, and quality teams, the Associate Director will drive submission planning, manage regulatory documentation, and coordinate cross-functional teams to deliver high-quality submissions in accordance with global and regional regulatory operations processes and systems. While primarily focused on the European region, this role operates within Global Regulatory Operations and may support regulatory submissions in other regions as business needs evolve.

Primary Responsibilities:

• Serve as the primary Regulatory Operations partner supporting the European Regulatory Affairs team to execute regional regulatory strategies.

• Lead operational planning, preparation, publishing, and submission of regulatory dossiers to European health authorities including EMA, EU/EEA national authorities, MHRA, and Swissmedic.

• Lead regulatory submission planning and operational execution for major regulatory applications including Marketing Authorisation Applications (MAA), ensuring effective coordination of submission timelines, dossier assembly, publishing, and submission readiness.

• Develop and manage detailed regulatory submission timelines, proactively driving cross-functional teams to ensure timely preparation, review, and delivery of submission components.

• Coordinate cross-functional activities required for regulatory submissions, including document preparation, review cycles, and final submission readiness.

• Publish and perform quality control of regulatory submissions in eCTD format using DocuBridge, ensuring compliance with applicable regulatory technical requirements.

• Manage regulatory submission content and metadata within Veeva Vault RIM, ensuring accuracy and completeness of regulatory information and documentation.

• Support preparation and coordination of key regulatory deliverables including Clinical Trial Applications (CTA), scientific advice packages, pediatric plans, and lifecycle management submissions.

• Provide operational guidance to cross-functional teams regarding submission requirements, document standards, and regulatory timelines.

• Partner with Global Regulatory Operations to ensure alignment of regional submission processes, systems, and regulatory documentation standards.

• Manage external publishing vendors and consultants supporting regulatory submission activities.

• Provide regulatory operations support for global submissions as needed, collaborating with Global Regulatory Operations colleagues across regions.

• Manage regulatory procedures via EMA IRIS platform, including scientific advice, orphan designation, and other applicable EMA interactions.

• Ensure accuracy, completeness, and consistency of structured regulatory data and metadata across Veeva Vault RIM and European health authority systems (e.g., CTIS, IRIS, eSubmission Gateway).

• Coordinate submission activities across multiple European submission channels and platforms, ensuring alignment of dossier content and data across eCTD and portal-based submissions.

• Lead operational support for EU regulatory lifecycle activities, including variations, renewals, and other post-approval submissions, ensuring compliance with EU procedural requirements.

Required Skills, Experience and Education:

• Bachelor’s degree in life sciences or related discipline.

• 8+ years of experience in regulatory operations, regulatory affairs, or regulatory submission management within the biotechnology or pharmaceutical industry.

• Demonstrated experience preparing and publishing eCTD submissions to global health authorities.

• Strong understanding of European regulatory submission requirements and procedures.

• Hands-on experience using Veeva Vault RIM for regulatory information management.

• Hands-on experience using DocuBridge for regulatory publishing.

• Demonstrated ability to lead regulatory submission timelines and coordinate cross-functional submission deliverables.

• Strong understanding of regulatory document management, publishing standards, and regulatory submission lifecycle processes.

• Proven ability to manage multiple complex regulatory submissions simultaneously while maintaining high quality and compliance.

• Strong organizational, communication, and stakeholder management skills.

• Familiarity with EMA IRIS platform and associated regulatory procedures (e.g., scientific advice, orphan designation).

• Experience managing regulatory data, metadata, and submission tracking across multiple health authority systems and platforms.

Preferred Skills:

• Experience supporting regulatory submissions to European health authorities including EMA, MHRA, Swissmedic, or EU national competent authorities.

• Experience supporting Marketing Authorisation Applications (MAA) or other major marketing applications.

• Experience working in global regulatory teams supporting both regional and global regulatory submissions.

• Oncology or rare disease regulatory experience is considered an advantage.

• Experience managing regulatory publishing vendors or external regulatory consultants.

• Experience working within a growing or evolving regulatory organization.

• Experience navigating EU regulatory procedures (centralised, decentralised, or mutual recognition).

• Familiarity with evolving EU regulatory data standards (e.g., SPOR/IDMP) is a plus.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-Hybrid #LI-LO1

The Opportunity:

As part of our expanding European organization, we seek a strategic and hands-on Director, CMC Regulatory, Europe who will be responsible for developing and executing regional CMC regulatory strategies to support early development, marketing authorizations, and lifecycle management across Europe.

This role is responsible for ensuring successful interactions with the European Medicines Agency (EMA), national competent authorities (NCAs), and other regional regulatory bodies. It provides leadership across early- and late-stage CMC regulatory activities, including clinical trial applications, initial marketing authorization applications (MAA), post-approval variations, and lifecycle strategy.

The position requires deep expertise in EU regulatory frameworks, strong cross-functional collaboration, and the ability to proactively identify and manage regulatory risks while supporting business objectives.

Primary Responsibilities:

• Provide CMC regulatory support for clinical trial applications and regulatory interactions, ensuring alignment with EU requirements and timelines.

• Develop and lead execution of European CMC regulatory strategies to support initial marketing authorizations and lifecycle management of the company’s product portfolio.

• Oversee preparation, review, and submission of high-quality CMC dossiers for EU MAAs, variations, renewals, and line extensions.

• Serve as the primary CMC regulatory lead for Europe, managing interactions with EMA, NCAs, and other European regulatory bodies.

• Provide strategic input into global regulatory strategies, ensuring alignment while addressing EU-specific requirements and expectations.

• Assess regulatory impact of CMC changes and provide proactive, risk-based guidance to ensure compliance with EU regulations.

• Interpret and apply EU regulatory requirements (EMA, ICH, EU GMP, and national guidance) to support efficient regulatory pathways, ensure compliance, and proactively monitor and communicate evolving regulatory expectations across functions.

• Anticipate regulatory risks and develop mitigation strategies aligned with European approval timelines.

• Partner with global Regulatory Affairs, Quality, Technical Operations, and external partners to ensure consistent and compliant execution of submissions.

• Represent CMC regulatory on European or global cross-functional teams, ensuring alignment between global strategy and regional execution.

• Provide leadership, mentorship, and technical guidance to team members and contribute to building regional CMC regulatory expertise.

• Oversee external vendors and CROs to ensure timely, high-quality regulatory submissions and approvals.

Required Skills, Experience and Education:

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline. An advanced degree (PhD, PharmD, MSc) is desirable.

• Minimum of 15 years of experience in pharmaceutical/biotech drug development, including at least 5 years in CMC regulatory affairs with European focus.

• Strong expertise in EU CMC regulatory requirements, including MAAs, variations, and lifecycle management.

• Direct hands-on experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities

• Demonstrated experience supporting EMA submissions and interactions.

• Deep knowledge of EU GMP regulations and ICH guidelines, with ability to apply across the product lifecycle.

• Experience with small molecules (NCEs) and managing complex CMC technical documentation.

• Proven ability to lead regulatory strategy for European approvals within global development programs.

• Strong leadership and project management skills with ability to manage multiple complex programs.

• Excellent communication and stakeholder management skills, including experience working cross-functionally and with external partners.

• Ability to operate effectively in a fast-paced, matrixed, global environment.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-Remote #LI-LO1

Cytokinetics is dedicated to upholding the highest standards of excellence to bring potential medicines to patients to improve outcomes and quality of life. We are looking for Regulatory Affairs professionals who bring a strategic mindset and a deep understanding of the regulatory environment. As a member of the team, you will play a crucial role in ensuring our processes meet regulatory requirements while maintaining high standards of compliance.

Cytokinetics is seeking an experienced Director, Regulatory Affairs Europe to join the Regulatory Affairs team in Europe. He/she will provide leadership in developing and executing best in class regulatory strategies for assigned programs in the European region. The Director will lead regulatory activities related to the submission of Marketing Authorization Applications of assigned Cytokinetics products in Europe  as well as implementation of post-marketing requirements.

The Director, Regulatory Affairs Europe will work closely with the Global Regulatory Lead and be a member of the Global Regulatory Team. He/she will work cross-functionally including with Clinical Research, Medical Affairs, Drug Safety, Quality, Market Access and with country operations to ensure all regional and local regulatory requirements are met.  

The Director will also maintain awareness of the regulatory environment and communicate the impact of changes on business and product development programs.

This position offers a temporary contract till end of the year, with possibility of extension. The work set up is hybrid, with 2-3 days per week in our centrally located Zug office, and the rest of the time from home.

Responsibilities

• Develop a robust European strategy for specific products aligning with the Global regulatory strategy and cross functionally identify the best strategy that will lead to European approval.
• Contribute and independently execute the filing plans for Europe in line with corporate, regional and local business objectives.
• Ensure high-quality regulatory submissions are made on time and meet Cytokinetics requirements.
• Collaborate with the Regulatory Study Lead to review and provide strategic input/advice to EU CTR submissions and/or queries.
• As part of the Global Regulatory Team (GRT), provide direction and expertise on regional and local regulatory mechanisms to optimize product development
• Provide strategic and operational contributions to EMA/national agencies interactions and their preparation
• Maintain an awareness of new and developing legislation, regulatory policy and technical guidance relating to Cytokinetics products and discuss their implications with business.
• Oversees regulatory-related launch and post-marketing activities in the EU:
• Provides regulatory input to market access strategy and HTA plans and submissions in the EU
• Ensures all post-marketing requirements and maintenance activities are met.
• Work closely with the Quality department on relevant regulatory procedures applicable to the European region

Qualifications

• Seasoned professional with a minimum of 10 years of relevant experience with a solid expertise and knowledge of the applicable European regulatory regulations, directives and guidelines.
• Bachelor of Science in a scientific discipline, Pharm D (/Pharmacist) or PhD preferred. Fluency in English, and any other key EU market languages are an advantage.
• Proven track record of directly leading Marketing Authorization Applications through EMA centralized procedure and national agencies (including Switzerland and UK). Experience in international markets is advantageous.
• Strong experience leading or participating in regulatory agency interactions.
• Solid foundation in science obtained through academics and business experience.
• Must be a strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Strong interpersonal capabilities and ability to build and maintain networks.
• Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.

#LI-HYBRID

At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.

Reporting to the Executive Director, Regulatory Affairs - CMC, the Director of Regulatory Affairs-CMC is responsible for leading regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international regulatory submission strategies.

Responsibilities

• Formulate CMC regulatory strategies, without supervisor oversight, based on current regulatory intelligence.
• Collaborates with cross-functional project teams and external business partners to develop CMC regulatory strategies and identify regulatory risks; represents the department in cross-functional project teams.
• Identifies the required documentation and any content, quality and timeline issues for global submissions and manages the delivery of approved technical documents in accordance with project timelines.
• Manages the preparation, authoring and maintenance of regulatory submission documents pertaining to CMC data for global clinical trial and marketing applications, as well as post-marketing variations. May require technical regulatory authoring of submission package components.
• Supports the evaluation of manufacturing changes for the potential impact on products.
• Provides expert review of CMC documentation supporting regulatory submissions and communications.
• Coordinates preparation of responses to queries from regulatory authorities, particularly focused on CMC. May require technical regulatory authoring to support responses to queries.
• Maintains knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs.
• Ensures conformance to commitments made with various regulatory agencies (e.g., IND/CTA commitments) for assigned programs.
• Provides regulatory advice to other functional areas.
• May participate in regulatory due diligence activities.

Relationships

• Build and maintain collaborative relationships with internal/external business partners to achieve project regulatory goals.
• Develops and maintains collaborative relationships with other departments to ensure effective communication regarding project regulatory goals, issues and timelines.
• Develop and manage relationships with external vendors and regulatory health authorities.
• Coordinates activities for meetings and conferences with FDA, EMA, and other regulatory authorities
• Collaborate with regulatory colleagues to provide CMC expertise as needed.

Management

• This is an Individual Contributor position; however, there is the possibility for supervising consultants/contractors and/or interns.
• Develops and implements regulatory operating guidelines and common work practices/strategies within the team.

Qualifications

• 10 - 12+ years of related work experience (Director candidates will typically bring 12+ years; Associate level candidates may be considered with 10+ years and strong potential), including 8+ years in Regulatory Affairs CMC in the Biotech/Pharmaceutical industry; experience in small molecule drug development required; experience in the cardiovascular therapeutic area is a plus
• Proven experience serving as a primary RA-CMC contact to Health Authorities, with full strategic responsibility.
• Bachelor’s degree is required, preferably in chemistry or a closely related field; advanced degree is a plus.
• Advanced degree is preferred.
• Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP
• Solid working knowledge of core processes associated with discovery, development, and manufacturing of small molecules.
• Experience with eCTD requirements and electronic submissions
• Experience with international regulatory submissions and processes is a strong plus.
• Ability to work effectively across teams, functions and with outside partners.
• Excellent oral and written communication skills
• Excellent organizational skills and attention to detail

#LI-HYBRID