Sanofi · 1 week ago
Head of Global Regulatory Affairs, CMC Small Molecule
Morristown, NJ
Full-time
Onsite
Director/Executive
10+ years expSanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives. The Head of Global Regulatory Affairs, CMC Small Molecule will lead the Global Regulatory Affairs CMC & Device Organization, ensuring compliance with regulatory requirements while optimizing product approval pathways across the product lifecycle.
Health CareLife SciencePharmaceuticalTherapeutics
Responsibilities
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. Demonstrates the knowledge and behaviors that model the Sanofi and GRA Values/Principles/Competencies
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. Assures that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities, and risks are identified, communicated, and mitigated as necessary
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; assures that contacts with Agencies are initiated and addressed in an effective and timely manner, whilst developing positive and favorable relationships with Agencies
Oversees the preparation review and approval of Regulatory CMC submissions (including writing as applicable), for all development projects and marketed products to assure that they meet appropriate quality standards; strategies and mitigated risks are developed and communicated, and deadlines are achieved. Assures directly that complex technical and regulatory CMC issues are appropriately resolved with optimal solutions. As applicable, support the regulatory inspection process for development projects and marketed products
Provides a vision and leadership for Policy and Regulation to assure that appropriate Sanofi representation in external activities is achieved. Monitors the review of local and international Agency regulations and guidelines. Assures that current Agency thinking, and trends (paradigm shifts) are understood and broadly communicated. Assures that associates take a leadership role externally, as appropriate, and that input is provided to position papers developed by external industry organizations and professional associations
Qualification
Required
Global Leadership experience with a mid-size/large Regulatory CMC organization, including organizational design, people leadership and development (supervising, coaching, mentoring), recruitment, retention, talent management and succession planning
Strong knowledge of key Agency/Industry thinking, trends and regulations / guidelines and be capable of resolving complex strategic technical and regulatory issues
Bachelor's degree required
Demonstrated excellent communication and influencing skills internally and externally
Demonstrated ability to assess regulatory risks, identify opportunities, and develop pragmatic solutions that align with business objectives
Demonstrated independence in thinking, anticipatory foresight, and be able to communicate effectively to broad, sophisticated, formal/informal, internal and external audiences
Experience building and maintaining effective partnerships across functions and with external stakeholders, including health authorities
20% travel expected, domestic and international
Preferred
Minimum 10-15 years of direct Regulatory CMC experience preferred, with demonstrated progression in regulatory affairs roles and successful regulatory authority interactions
Experience working for a Regulatory Health Authority is helpful but not essential
Advanced degree (Masters, PhD) in a science or health field (i.e., Analytical, Chemistry, Pharmacy, Biological / Biotechnology Sciences, etc.), or equivalent is highly desirable
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2026-01-23
2026-01-23
2026-01-23
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