Job title: GRA-CMC Lead Small Molecule
About the jobAs GRA-CMC Lead Small Molecule within
our Global Regulatory Affairs Small Molecule team, you'll shape and lead global regulatory CMC strategies for both development and marketed products, working at the intersection of science, regulation, and innovation to bring life-changing medicines to patients worldwide. Ready to get started?
Main Responsibilities:- Develop and implement global regulatory CMC strategies for both development and marketed small molecule products, executing and adapting them to meet evolving regulatory and business needs
- Act as direct liaison with agencies such as the US FDA and EMA, build positive relationships and supporting strategic negotiations worldwide
- Prepare, review, and approve regulatory CMC dossiers, ensuring they meet quality standards, comply with regulatory requirements, and remain accurate and complete throughout the product lifecycle
- Lead cross-functional collaboration with R&D, Manufacturing & Supply, and Regulatory Operations teams to ensure effective implementation of regulatory strategies and timely resolution of CMC issues
- Identify and manage regulatory risks by assessing CMC opportunities, developing mitigation strategies, and clearly communicating risk/benefit implications to project teams and stakeholders
- Contribute to regulatory science and policy activities by participating in the review of new regulations and anticipating potential shifts in the regulatory landscape that may impact Sanofi's portfolio
- Lead high-impact regulatory strategies for global development and marketed products, directly influencing the approval and success of life-changing treatments
- Build expertise in cutting-edge regulatory science while working directly with the FDA, EMA, and other major Health Authorities worldwide
- Shape the future of regulatory CMC by contributing to policy development and representing Sanofi's interests in global regulatory initiatives
About youEducation- Bachelor's degree in a scientific discipline required; advanced degree (Masters or PhD) in a science, health-related and/or regulatory field is preferred.
Experience- At least 2 years of background in the pharmaceutical industry, with solid CMC regulatory experience, proven track record in preparing and managing regulatory filings and responding to Health Authority questions related to submissions.
Soft and technical skills- Excellent communication skills (concise, informative, and persuasive)
- Strong organizational abilities
- Experience working in matrix environments
- Ability to thrive in fast-paced settings across multiple product lines
- Foundational understanding of Artificial Intelligence and its impact on industry
Language- Fluency in English is required
Why choose us?- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
The salary range for this position is:
$122,250.00 - $176,583.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
