Job title: GRA CMC Lead

• Location: Morristown, NJ

About the job

As GRA CMC Lead within our R&D team, you will shape and lead global regulatory CMC strategies for both development and marketed small molecule products, working at the intersection of science, regulation, and innovation to bring life-changing medicines to patients worldwide. Within Sanofi's Global Regulatory Affairs CMC organization, this role serves as a critical strategic partner, bridging the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways across the product lifecycle.

In this role, you will develop and implement global regulatory CMC strategies, act as direct liaison with agencies such as the US FDA and EMA to build positive relationships and support strategic negotiations worldwide, and prepare, review, and approve regulatory CMC dossiers ensuring they meet quality standards and comply with regulatory requirements throughout the product lifecycle. You will lead cross-functional collaboration with R&D, Manufacturing & Supply, and Regulatory Operations teams, identify and manage regulatory risks by assessing CMC opportunities and developing mitigation strategies, and 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.

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

About you

Education

• Bachelor's degree in a scientific discipline required; advanced degree (Master's or PhD) in a science, health-related and/or regulatory field is preferred.

Experience:

• At least 4 years of experience/background in the pharmaceutical industry with solid CMC regulatory experience in small molecules; with 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

Languages

• Fluency in English is required

Why Choose Us

• Bring the miracles of science to life alongside a supportive, futurefocused 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.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.

The salary range for this position is:
$148,500.00 - $214,500.00

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.