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. 

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The mission of Speechify is to make sure that reading is never a barrier to learning.

Over 50 million people use Speechify’s text-to-speech products to turn whatever they’re reading – PDFs, books, Google Docs, news articles, websites – into audio, so they can read faster, read more, and remember more. Speechify’s text-to-speech reading products include its iOS app, Android App, Mac App, Chrome Extension, and Web App. Google recently named Speechify the Chrome Extension of the Year and Apple named Speechify its App of the Day.

Today, nearly 200 people around the globe work on Speechify in a 100% distributed setting – Speechify has no office. These include frontend and backend engineers, AI research scientists, and others from Amazon, Microsoft, and Google, leading PhD programs like Stanford, high growth startups like Stripe, Vercel, Bolt, and many founders of their own companies.

Overview

With the growth of our iOS app, being the #18 productivity app in the App Store category and also our recent recognition as Apple's 2025 Design Award for inclusivity, we find the need for a Senior iOS Engineer to help us support the new user base as well as work on new and exciting projects to push our missing forward.   

This is a key role and ideal for someone who thinks strategically, enjoys fast-paced environments, passionate about making product decisions, and has experience building great user experiences that delight users.

We are a flat organization that allows anyone to become a leader by showing excellent technical skills and delivering results consistently and fast. Work ethic, solid communication skills, and obsession with winning are paramount. 

Our interview process involves several technical interviews and we aim to complete them within 1 week. 

What You’ll Do

• Opportunity to lead key engineering and product decisions
• Actively shipping production code for the Speechify iOS app
• Work within a dedicated product team
• Participate in product discussions to shape the product roadmap
• Maintain and enhance the existing complex app architecture

An Ideal Candidate Should Have

• Experience. You've worked on products that scaled to a large user base
• Track record. You have worked on various products from inception to decent traction. You have been responsible for engineering the product
• Customer obsession. We expect every team member whose responsibilities directly impact customers to be constantly obsessed about providing the best possible experience
• Product thinking. You make thoughtful decisions about the evolution of your product and support internal teams and designers into taking the right direction
• Speed. You work quickly to generate ideas and know how to decide which things can ship now and what things need time
• Focus. We’re a high-growth startup with a busy, remote team. You know how and when to engage or be heads down
• Technical skills. Swift, SwiftUI

Technical Requirements:

• Swift Programming Language
• SwiftUI experience
• Experience in Multithreading Programming
• Working with CI/CD infrastructure
• Experience with Fastlane
• SOLID principles, the ability to write every single class according to SOLID
• Experience with Git and understanding of different Git strategies

What We offer:

• A fast-growing environment where you can help shape the company and product
• An entrepreneurial crew that supports risk, intuition, and hustle
• The opportunity to make a big impact in a transformative industry
• A competitive salary, a collegiate atmosphere, and a commitment to building a great asynchronous culture
• Work on a product that millions of people use and where daily feedback includes users sharing that they cried when they first found the product because it was so impactful on their lives
• Support people with learning differences like Dyslexia, ADD, Low Vision, Concussions, Autism, and Second Language Learners, and give reading superpowers to professionals all over the world
• Work in one of the fastest growing sectors of tech: Intersection of Artificial Intelligence and Audio

Think you’re a good fit for this job? 

Tell us more about yourself and why you're interested in the role when you apply.
And don’t forget to include links to your portfolio and LinkedIn.

Not looking but know someone who would make a great fit? 

Refer them! 

Speechify is committed to a diverse and inclusive workplace.

Speechify does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

The mission of Speechify is to make sure that reading is never a barrier to learning.

Over 50 million people use Speechify’s text-to-speech products to turn whatever they’re reading – PDFs, books, Google Docs, news articles, websites – into audio, so they can read faster, read more, and remember more. Speechify’s text-to-speech reading products include its iOS app, Android App, Mac App, Chrome Extension, and Web App. Google recently named Speechify the Chrome Extension of the Year and Apple named Speechify its Design award winner for inclusivity for 2025.

Today, nearly 200 people around the globe work on Speechify in a 100% distributed setting – Speechify has no office. These include frontend and backend engineers, AI research scientists, and others from Amazon, Microsoft, and Google, leading PhD programs like Stanford, high growth startups like Stripe, Vercel, Bolt, and many founders of their own companies.

Overview

With the growth of our Android app, being the most used text-to-speech app in the Play Store, we find the need for a Senior Android Engineer to help us support the new user base as well as work on new and exciting projects to push us forward.   

This is a key role and ideal for someone who thinks strategically, enjoys fast-paced environments, passionate about making product decisions, and has experience building great user experiences that delight users.

We are a flat organization that allows anyone to become a leader by showing excellent technical skills and delivering results consistently and fast. Work ethic, solid communication skills, and obsession with winning are paramount. 

Our interview process involves several technical interviews and we aim to complete them within 1 week. 

What You’ll Do

• Owning major features and working closely with our design team - take ownership of features inside the app and become responsible of delivering high quality features
• Shape the future of our Android team
• Own, maintain and improve reliability metrics for key features
• Participate in discussions across different teams - Product, Design, Engineering
• Review pull requests, and support other teammates
• Handle critical issues or cope with unexpected challenges 
• Take ownership of feature releases and provide nightly builds for the QA team

An Ideal Candidate Should Have

• 5+ years of software engineering experience
• Familiarity with Android components
• Experience building or contributing to at least one Android app
• Product design intuition and user empathy
• Drive to push the boundaries of Android UI/UX
• Understanding of the importance of tests and how to approach writing tests
• Self-drive to improve the app and codebase above and beyond what's outlined in the spec
• Rock solid experience with Kotlin, Kotlin Coroutines, Kotlin Flow, Dagger 2, MVVM, Clean Architecture, Background Services, Music Player Service, Android Animations, Jetpack Navigation, JUnit tests
• Excellent communication skills
• User oriented problem solving approach
• Driven with continuous feedback from leaders

Bonus:

• Experience building, maintaining, or otherwise contributing to open source projects in Android
• Experience with iOS, Web or NodeJS

Technologies we use:

• Kotlin
• Kotlin Coroutines
• Kotlin Flow
• Jetpack Navigation
• Dagger 2
• Room
• Custom Views, Canvas & Paint
• Jetpack Compose
• JUnit

What We offer:

• A fast-growing environment where you can help shape the company and product.
• An entrepreneurial-minded team that supports risk, intuition, and hustle.
• A hands-off management approach so you can focus and do your best work.
• An opportunity to make a big impact in a transformative industry.
• Competitive salaries, a friendly and laid-back atmosphere, and a commitment to building a great asynchronous culture.
• Opportunity to work on a life-changing product that millions of people use.
• Build products that directly impact and support people with learning differences like dyslexia, ADD, low vision, concussions, autism, and more.
• Work in one of the fastest growing sectors of tech, the intersection of artificial intelligence and audio.

Think you’re a good fit for this job? 

Tell us more about yourself and why you're interested in the role when you apply.
And don’t forget to include links to your portfolio and LinkedIn.

Not looking but know someone who would make a great fit? 

Refer them! 

Speechify is committed to a diverse and inclusive workplace. 

Speechify does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

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. 

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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. 

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