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

Join Proton and build a better internet where privacy is the default

Proton was founded in 2014 by scientists from CERN on a simple truth: privacy is a fundamental human right. Since then, we've built the world's largest encrypted email service (Proton Mail) and expanded into Proton VPN, Proton Drive, Proton Pass, and Proton Calendar — tools used by millions globally to protect their freedom, fight censorship, and keep their data safe. In some situations, Proton has literally helped save lives.

We are profitable, independent (no VC control), and selectively hire from the top ~1% of applicants. Our 700+ team members across 50+ countries come from leading organizations and elite academic backgrounds. We move fast, keep hierarchy light, and prioritize impact over optics. If you want to do meaningful work with exceptionally high-caliber people, this is it. Check our open-source projects here.

The Role

As VP Design, you will own and lead the design function across both Product Design (user experience, interface, service design) and Brand / Marketing Design (visual identity, campaign creative, brand experience). You’ll partner closely with the CEO, VP Marketing and Heads of Product, helping shape strategy, drive design excellence, and ensure that design becomes a core differentiator for Proton. You will build, mentor and scale a high-performing, multi-disciplinary design organisation, embedding design thinking across the company.

What you will do
• Define and execute the strategic vision for design at Proton, bridging product and brand to deliver a unified and differentiated experience globally.
• Lead, develop and grow a world-class design organisation: recruiting designers and researchers structuring teams across product and brand, setting performance metrics, fostering a culture of creativity, craft and user-centricity.
• Partner with the CEO, VP Marketing and Heads of Product to ensure design is embedded into strategic roadmaps, product launches, marketing campaigns and brand initiatives.
• Oversee the end-to-end design process for all major product lines and brand campaigns: user research, UX/UI, service design, prototyping, testing, visual design, motion, interactive experiences.
• Ensure that the Proton brand identity is strong, consistent, scalable and flexible across all touchpoints: digital, mobile, web, marketing, physical, events.
• Drive design systems, tools and processes across product & brand to deliver efficiency, quality, consistency and scale.
• Advocate for users and privacy-first design principles in everything we build and brand.
• Monitor and measure design impact: user experience metrics, brand perception, conversion, retention, campaign effectiveness; iterate and optimise accordingly.
• Represent design externally: speak on design at conferences, build Proton’s design reputation, collaborate with creative agencies and partners worldwide.

What We’re Looking For
• A minimum of 15 + years of experience in design leadership roles (product, brand and/or marketing) at a global technology company or agency.
• Proven track record of building, scaling and operating design organisations with cross-functional reach.
• Strong experience overseeing both product (UX/UI, service design) and brand/marketing design (visual identity, campaign creative) — not one or the other only.
• Demonstrated ability to define and execute design strategy that drives business impact (growth, engagement, retention, brand equity).
• Excellent stakeholder management skills, with the ability to work at executive level and influence across product, marketing, engineering and operations.
• Deep user-centred design mindset; strong portfolio showing end-to-end work (research → strategy → UX → UI → brand visuals).
• Skilled in designing for global audiences, with sensitivity to cultural differences and brand consistency across markets.
• Expertise in building and scaling design systems, establishing best practices and operational processes in fast-growing environments.
• Excellent leadership and people development skills: mentoring senior designers, creating high-performing teams, promoting a culture of craftsmanship and innovation.
• Comfortable working in a dynamic, high-growth company with a mission-driven ethos and a global, diverse team.
• Strong communicator with polished presentation and storytelling skills; fluent in English (other languages a plus).

What We Offer

• Work that Matters: Millions of people trust Proton with their privacy. We answer only to our users — not advertisers, not investors with conflicting agendas, not governments.
• A Great Team: Diverse, collaborative, and tight-knit, with people from MIT, Harvard, Stanford, Caltech, Cambridge, ETH, and more.
• Technology: The right hardware and software to do your best work.
• Learning & Development: We invest in your growth. Proton is one of the fastest ways to accelerate your career — real challenges, real ownership, from day one.
• Employee Benefits: Strong health coverage, solid retirement options, generous leave, and wellness support.
• Stock Options: From day one, you have a real stake in what we're building. When Proton wins, you win.
• In-Person Collaboration: Offices across Geneva, Zürich, Barcelona, London, and more. You'll spend most of your time collaborating face-to-face.
• Food: Lunch and snacks on us every day in the office.
• Transport: We cover public transport, bike allowances, or parking — whichever works for you.
• Flexible Working: You own your schedule. Outcomes matter more than clock-in times.

Our Commitment to Diversity and Inclusion

At Proton, we believe diversity drives innovation and strengthens our mission to provide privacy as a default for all. We are committed to fostering an inclusive environment where all individuals — regardless of race, ethnicity, gender, age, sexual orientation, physical ability, or socio-economic background — feel valued and empowered.

If you need any extra support or reasonable adjustments during the hiring process, please let your talent partner know.

Candidate Privacy Notice

When you apply for a position at Proton Technologies AG, your information is stored in Greenhouse in accordance with its Service Privacy Policy. This information is used to evaluate your suitability for the posted position and may be retained for future roles.

If we no longer have a legitimate business need to process your information, we will either delete or anonymise it. For questions about your data, contact: careers@proton.ch

Proton does not accept unsolicited CVs from any sources other than directly from candidates.

#LI-ONSITE

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

Location
Our Sales Development Representative will be an integral part of our DoiT Cloud Intelligence (DCI) sales team. This role is fully remote. We are hiring for this position in EMEA in the UK, the Netherlands, Sweden, Germany and Switzerland. 

Who We Are
DoiT is a global technology company that works with cloud-driven organizations to leverage the cloud to drive business growth and innovation. We combine data, technology, and human expertise to ensure our customers operate in a well-architected and scalable state - from planning to production. 

Delivering DoiT Cloud Intelligence, the only solution that integrates advanced technology with human intelligence, we help our customers solve complex multicloud problems and drive efficiency.

With decades of multicloud experience, we have specializations in Kubernetes, GenAI, CloudOps, and more. An award-winning strategic partner of AWS, Google Cloud, and Microsoft Azure, we work alongside more than 4,000 customers worldwide.

The Opportunity
As a Sales Development Representative for DoiT Cloud Intelligence (DCI), you will be responsible for outbound lead generation, including email, calling, and using LinkedIn to book demos with qualified prospects in your region. You’ll be on the front line of the sales team, collaborating closely with the regional Field Sales teams and progress the qualified pipeline with Account Executives (AE) by focusing on the primary metrics of qualified meetings booked and pipeline generated. We are looking for an agile, "startup-minded" individual who is ready to learn quickly and evolve as we scale. You will also build internal relationships with our sales, marketing, and cloud vendor teams. 

Responsibilities

• Set meetings via outbound prospecting through both automated and manually-driven campaigns to achieve daily and monthly pipeline targets.
• Partner closely with Account Executives to ensure tight alignment on territory planning, account prioritization, and feedback loops to maximize pipeline quality.
• Help build and refine our outbound motion by identifying and reaching decision-makers.
• Build, manage, and optimize multi-channel outbound campaigns at scale using various tools like LinkedIn Sales Navigator, ZoomInfo, Clay, etc. 
• Own the outbound process end-to-end, from detailed account research to ensuring a qualified meeting is successfully booked for the Account Executive team.
• Partner with leadership to refine messaging, call scripts, and multi-channel outreach strategies to improve conversion rates and outbound effectiveness.
• Support Regional GTM & Marketing activities across digital and onsite formats. 
• Clearly communicate compelling value propositions to technical buyers and stay current with the latest product and service information.
• Stay current with the latest offering/product/service information
• Some travel may be required 

Qualifications

• 1–3+ years of SDR/BDR experience in Cloud, preferably with a background in selling to technical decision makers such as CTO, VP Engineering or Head of DevOps.
• Proven experience selling SaaS B2B  or cloud products or services.
• Proven history of achieving and reaching for results in an outbound lead generation environment.
• Experience managing multiple priorities and juggling various tools or campaigns in a fast-paced, evolving environment.
• Goal-oriented and self-motivated mindset with the "grit" to work through challenges and multiply sales speed.
• Ability to exercise a high degree of autonomy and sales authority while remaining highly organized.
• Excellent written and verbal communication skills in English. Additional languages such as Swedish, German, and Dutch are a plus. 

Are you a Do’er?
Be your truest self. Work on your terms. Make a difference. 

We are home to a global team of incredible talent who work remotely and have the flexibility to have a schedule that balances your work and home life. We embrace and support leveling up your skills professionally and personally.  

What does being a Do’er mean? We’re all about being entrepreneurial, pursuing knowledge and having fun! Click here to learn more about our core values. 

Sounds too good to be true? Check out our Glassdoor Page.  

We thought so too, but we’re here and happy we hit that ‘apply’ button. 

• Unlimited Vacation
• Flexible Working Options
• Health Insurance
• Parental Leave
• Employee Stock Option Plan
• Home Office Allowance
• Professional Development Stipend 
• Peer Recognition Program

Many Do’ers, One Team
DoiT unites as Many Do’ers, One Team, where diversity is more than a goal—it's our strength. We actively cultivate an inclusive, equitable workplace, recognizing that each unique perspective enhances our innovation. By celebrating differences, we create an environment where every individual feels valued, contributing to our collective success.

#LI-Remote

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