Head of Global Regulatory Affairs, CMC Small Molecule

About the job

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

Our Team / Overview:

The Global Regulatory Affairs (GRA) CMC & Device Organization serves as a critical strategic partner within Sanofi’s regulatory framework, providing expert guidance on Chemistry, Manufacturing, and Controls (CMC) 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.

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:

• Leadership: Provides leadership to their group and is accountable for organizational design, people development (supervising, coaching, mentoring), resource allocation (recruitment, retention, talent development, succession planning etc.), and metrics. Demonstrates very strong leadership including influencing and negotiating skills, and conflict management and resolution. Capable of resolving and/or advising on very complex global organizational and regulatory/technical issues.
• CMC Strategy: Oversees the development of CMC regulatory strategy and regulatory risk assessments for all development projects and marketed products, in collaboration with other parts of GRA. Assures that positive and collaborative relationships are developed with CMC and Device teams to achieve the implementation of appropriate global regulatory strategies.
• Agency Negotiations: Oversees strategic negotiations with worldwide Regulatory Agencies, including directly with FDA and EMA, so that appropriate and pragmatic Regulatory CMC positions are negotiated with the highest Probability of Success (POS). Assures appropriate representation of Sanofi at Agency meetings.
• Submissions & Compliance: Oversees the preparation, review, and approval of Regulatory CMC submissions for all development projects and marketed products to assure they meet quality standards and deadlines. As applicable, supports the regulatory inspection process.
• Policy & Vision: Provides a vision and leadership for Policy and Regulation to assure appropriate Sanofi representation in external activities. Monitors the review of local and international Agency regulations and guidelines, ensuring current Agency thinking and trends are understood and communicated.

About You

Qualifications:

• Core Experience: Minimum 10-15 years of direct Regulatory CMC experience preferred, with demonstrated progression in regulatory affairs roles and successful regulatory authority interactions.
• Leadership Background: Global Leadership experience with a mid-size/large Regulatory CMC organization, including organizational design, people leadership, recruitment, and talent management.
• Global Regulations/Guidelines: Strong knowledge of key Agency/Industry thinking, trends, and regulations/guidelines. Experience working for a Regulatory Health Authority is helpful but not essential.
• Education: Bachelor’s degree required. Advanced degree (Masters, PhD) in a science or health field (i.e., Analytical, Chemistry, Pharmacy, Biological / Biotechnology Sciences, etc.) is highly desirable.
• Communication Skills: Demonstrated excellent communication and influencing skills internally and externally.
• Strategic Thinking: Ability to assess regulatory risks, identify opportunities, and develop pragmatic solutions that align with business objectives.
• Collaborative Leadership: Experience building and maintaining effective partnerships across functions and with external stakeholders.
• Travel: 20% travel expected, domestic and international.

The above information was designed to indicate the general nature and level of work performed. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities.

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.
• 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 at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, protected veteran status, or other characteristics protected by law.

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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. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

Apply here