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Global Regulatory Affairs CMC Lead

Location: Waterford, Ireland
Hiring Manager: Rebecca Berger
Grade: L3

About the Job

As Global Regulatory Affairs CMC Lead within our GRA CMC & GRA Device Organization, you’ll drive global regulatory strategies for pharmaceutical and vaccine products, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence the success of drug approvals through strategic negotiations with health authorities worldwide. Ready to get started?

Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role offers the opportunity to drive regulatory strategy for pharmaceutical products and vaccines across their lifecycle. Working at the intersection of science and compliance, you'll develop CMC strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities including FDA and EMA. You'll collaborate across R&D, Manufacturing, and Quality teams while preparing high-quality regulatory submissions, managing compliance, and anticipating regulatory trends—all contributing directly to bringing innovative therapies to patients worldwide.

What is CMC Regulatory Experience?
CMC stands for Chemistry, Manufacturing, and Controls—a critical area in pharmaceutical development that covers the technical and quality aspects of drug manufacturing and product control. CMC regulatory experience means managing and preparing submissions to regulatory agencies related to the manufacturing process, quality standards, product specifications, and control methods. This experience ensures that products meet all regulatory requirements for safety, efficacy, and quality throughout their lifecycle. The role involves working closely with agencies like FDA and EMA, ensuring compliance with Good Manufacturing Practices (GMP), and managing changes and documentation to support drug approvals and post-approval activities.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

The Global Regulatory Affairs CMC & Device Organization within Sanofi R&D serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on Chemistry, Manufacturing, and Controls and medical device regulatory requirements across the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways. The team develops and implements global regulatory strategies for pharmaceutical products, biologics, vaccines, and combination products, working closely with cross-functional partners to navigate complex regulatory landscapes. With a commitment to Sanofi's Take the Lead values, particularly in Leading Together and Being Bold, our mission is to secure timely approvals while maintaining the highest standards of quality and compliance, ultimately supporting Sanofi's goal of bringing innovative healthcare solutions to patients worldwide.

Main Responsibilities

• Develop and implement global regulatory CMC strategies
• Create strategies for development and marketed products focusing on chemical entities, biological entities, and/or vaccine products
• Serve as the primary point of contact for regulatory authorities including FDA and EMA
• Act as direct liaison with agencies and develop positive relationships with regulators
• Support strategic negotiations with worldwide regulatory health authorities
• Manage CMC documentation and submissions ensuring quality standards and regulatory compliance
• Write, prepare, review, and approve regulatory CMC dossiers
• Maintain documentation accuracy and completeness
• Lead cross-functional collaboration with R&D, Manufacturing, Supply, and Regulatory Operations teams
• Facilitate resolution of CMC issues and ensure effective implementation of regulatory strategies
• Identify and manage regulatory risks, including risk assessments and mitigation strategies
• Communicate implications of regulatory risks to project teams and stakeholders
• Contribute to regulatory science and policy activities by monitoring health authority regulations and guidelines
• Participate in the review process for new regulations and anticipate potential regulatory paradigm shifts
• Track and communicate current health authority thinking and industry trends

About You

• Experience of at least 4 years in CMC regulatory roles, contributing to regulatory filings and implementation of regulatory strategies
• Proven ability to respond to health authority questions and prepare regulatory documentation
• Strong understanding of pharmaceutical development, manufacturing processes, and regulatory requirements in major markets
• Ability to collaborate effectively in a matrix environment, engaging R&D, Manufacturing, and Quality teams
• Bachelor’s degree in a scientific discipline such as Chemistry, Biology, Pharmacy, or related field
• Strong written and verbal communication skills with fluency in English
• Ability to manage multiple projects in a fast-paced, hybrid work environment with approximately 60% on-site presence
• Openness to learning, growth, and adapting to new challenges

Why Choose Us

• Play a crucial role in bringing innovative therapies to millions worldwide by working at the forefront of drug discovery and development with a patient-centric approach
• Leverage advanced AI, data, and digital platforms to push the boundaries of pharmaceutical science and regulatory strategy
• Engage with diverse teams spanning scientific, clinical, and digital fields, fostering breakthroughs through cross-functional collaboration
• Benefit from structured career paths offering both scientific and leadership advancement opportunities including bold moves and short-term projects to expand expertise
• Join a workplace that prioritizes diversity, equity, and inclusion with programs that celebrate every voice and perspective
• Enjoy a supportive R&D environment that values work-life balance, offering flexible working options with 60% on-site work and comprehensive well-being programs
• Influence global regulatory strategies, interact with key health authorities, and stay at the forefront of evolving industry trends and regulations

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