Global Regulatory Affairs CMC Lead

Job Title : Global Regulatory Affairs CMC lead

Location : Framingham, MA, Morristown, NJ

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

As GRA CMC Lead within our GRA CMC & GRA Device Organization, you'll drive global regulatory strategies for pharmaceutical and vaccine products, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence the success of drug approvals through strategic negotiations with health authorities worldwide.

Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role offers the opportunity to drive regulatory strategy for pharmaceutical products and vaccines across their lifecycle. Working at the intersection of science and compliance, you'll develop CMC strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities including FDA and EMA. You'll collaborate across R&D, Manufacturing, and Quality teams while preparing high-quality regulatory submissions, managing compliance, and anticipating regulatory trends—all contributing directly to bringing innovative therapies 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.

The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D 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.

We are an innovative global healthcare company with one purpose : to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started??

Main Responsibilities :

Develop and implement global regulatory CMC strategies

Create strategies for development and marketed products

Focus on chemical entities, biological entities, and / or vaccine products

Execute and adapt strategies as needed

Serve as the primary point of contact for regulatory authorities

Act as direct liaison with agencies like US FDA and EMA

Develop positive relationships with regulators

Support strategic negotiations with worldwide Regulatory Health Authorities

Manage CMC documentation and submissions

Write, prepare, review, and approve regulatory CMC dossiers

Ensure dossiers meet quality standards

Comply with regulatory requirements

Maintain documentation accuracy and completeness

Lead cross-functional collaboration

Work closely with R&D Functions

Collaborate with Manufacturing & Supply Functions

Coordinate with GRA Regulatory Operations

Ensure effective implementation of regulatory strategies

Facilitate resolution of CMC issues

Identify and manage regulatory risks

Assess regulatory CMC opportunities and risks

Develop risk mitigation strategies

Communicate implications to project teams

Articulate risk / benefit components to stakeholders

Contribute to regulatory science and policy activities

Monitor local and international Health Authority regulations and guidelines

Participate in the review process for new regulations

Anticipate potential regulatory paradigm shifts

Track and communicate current Health Authority thinking and trends

About You

Experience : 4+ years of CMC regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions.

Regulatory Expertise : Experience preparing regulatory documentation and familiarity with standard submission processes

Technical Knowledge : Understanding of pharmaceutical development, manufacturing processes, and regulatory requirements in major markets.

Collaboration Skills : Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Manufacturing, and Quality teams.

Education : Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field).

Communication : Strong written and verbal communication skills, with fluency in English.

Adaptability : Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth.

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, 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.

Play a crucial role in bringing innovative therapies to millions worldwide, working at the forefront of drug discovery and development with a patient-centric approach.

Leverage advanced AI, data, and digital platforms to push the boundaries of pharmaceutical science and regulatory strategy.

Engage with diverse teams spanning scientific, clinical, and digital fields, fostering breakthroughs through cross-functional collaboration.

Benefit from structured career paths offering both scientific and leadership advancement opportunities, including bold moves and short-term projects to expand your expertise.

Join a workplace that prioritizes diversity, equity, and inclusion, with programs that celebrate every voice and perspective.

Enjoy a supportive R&D environment that values work-life balance, offering flexible working options (60% on-site) and comprehensive well-being programs.

Influence global regulatory strategies, interact with key health authorities, and stay at the forefront of evolving industry trends and regulations.

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.