Head of Global Regulatory Affairs, CMC Small Molecule

Sanofi•Morristown, NJ

2d•$228,750 - $330,417•Onsite

About The Position

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

Requirements

Minimum 10-15 years of direct Regulatory CMC experience preferred, with demonstrated progression in regulatory affairs roles and successful regulatory authority interactions.
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.
Global Leadership experience with a mid-size/large Regulatory CMC organization, including organization 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

Nice To Haves

Advanced degree (Masters, PhD) in a science or health field (i.e., Analytical, Chemistry, Pharmacy, Biological / Biotechnology Sciences, etc.), or equivalent is highly desirable.
Experience working for a Regulatory Health Authority is helpful but not essential.

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.

Benefits

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.

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