GRA-CMC Lead Small Molecule

Description du poste:

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l'international, l'anglais étant la langue de travail.

The job posting is in English given the significant interactions required with our global subsidiaries, for which English is the working language
Job title: Regulatory Affair CMC Lead Small Molecule

* Location: Gentilly/ Campus Val de Bièvre

About the job

As regulatory affair 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?

The Global Regulatory Affairs CMC Organization serves as a critical strategic partner within Sanofi's regulatory framework, bridging the gap between technical development, manufacturing operations, and global regulatory authorities. Our GRA-CMC department ensures compliance while optimizing product approval pathways across the product lifecycle. The GRA-CMC Small Molecule team develops and implements global regulatory strategies for pharmaceutical synthetic products, guided by Sanofi's "Take the Lead" values particularly "Leading Together" and "Being Bold" to bring innovative healthcare solutions to patients worldwide.
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.

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
* Experience: 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
* Education: Bachelor's degree in a scientific discipline required; advanced degree (Masters or PhD) in a science, health-related and/or regulatory field is preferred
* Languages: Fluency in English is required

Ce que nous vous offrons :
* A fixed salary over 12 months, supplemented by individual variable compensation [, as well as profit-sharing & employee share ownership based on Sanofi Group results.
* Because taking care of our employees is also our mission: 31 days of paid leave + RTT days according to your status, remote work up to 2 days/week, quality health insurance, public transport coverage up to 80%; maternity leave (18 weeks) and parental leave for welcoming a child (14 weeks), Savings Plan & Retirement Plans with company matching, CSE benefits, internal and international mobility opportunities, a customizable training offer to support you throughout your career, and many other benefits to discover here.
*
Why choose us?
* 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

Pursue Progress. Discover Extraordinary.
Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what's never-been-done-before. You'll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people's lives? Let's Pursue Progress and Discover Extraordinary - together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
The salary range for this position is :EUR54 400,00 - EUR72 533
Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs