Regulatory Affairs CMC Project Lead

Job title: Regulatory Affairs CMC Project Lead

• Location: Morristown, NJ

About the job

As Regulatory Affairs CMC Project Lead within our R&D team, you will serve as a strategic regulatory expert who coordinates multiple cross-functional projects, provides senior-level CMC regulatory guidance, mentors team members, drives accountability for deliverables, and influences decision-making while ensuring regulatory compliance and alignment within Sanofi's "Take the Lead" values.

This role offers a dynamic opportunity at the intersection of regulatory expertise and innovative drug development. As part of this pioneering function, you'll provide strategic regulatory leadership across multiple projects, leveraging cutting-edge AI and digital platforms to accelerate development timelines. Working collaboratively with cross-functional teams, you'll influence critical decisions while mentoring colleagues in a diverse, inclusive environment that values every voice. This position offers exceptional growth opportunities through structured career paths and work-life balance, all while making a meaningful impact on millions of patients' lives through more effective and efficient drug development processes.

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.

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

• Coordinate multiple pharmaceutical projects, providing expert regulatory guidance while balancing priorities across different teams

• Apply your technical knowledge of pharmaceutical manufacturing to develop regulatory strategies that navigate complex global requirements

• Mentor and coach team members to build regulatory expertise across the organization, without having direct management responsibility

• Solve complex regulatory challenges by interpreting regulations creatively and identifying both opportunities and risks

• Lead health authority interactions and regulatory submissions, ensuring quality standards and deadlines are consistently met

• Influence key decisions across projects through your regulatory expertise, even without formal authority

• Foster collaboration across diverse teams while embodying Sanofi's "Take the Lead" values, particularly in "Leading Together" and "Being Bold"

About you

• Experience: Minimum 6+ years of CMC regulatory strategy experience, including managing regulatory projects and interacting with health authorities

• Mentoring: Experience guiding or mentoring junior staff, with a collaborative approach to developing team capabilities

• Technical Skills: Strong knowledge of CMC regulatory requirements in major markets and good understanding of pharmaceutical development and manufacturing processes

• Soft Skills: Effective communication and influencing abilities, with demonstrated success working in matrix environments and managing stakeholders

• Project Management: Ability to coordinate multiple projects simultaneously, prioritize effectively, and drive accountability for deliverables

• Education: B.S. or M.S. degree in a scientific discipline (advanced degree beneficial but not required)

• Language: Fluency in English (written and spoken)

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 drugdevelopment quicker and more effective.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.