🌍 Job Title: Global Regulatory Affairs CMC Lead
🏢 Company: Sanofi
📍 Location:
Morristown, New Jersey, USA
Framingham, Massachusetts, USA
💰 Salary Range:
USD 122,250.00 – 176,583.33
🔬 About the Job
Are you ready to shape the future of medicine?
As a Global Regulatory Affairs (GRA) CMC Lead within Sanofi’s GRA CMC & Device Organization, you will drive global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for pharmaceutical and vaccine products across their lifecycle.
This role sits at the intersection of science, compliance, and innovation, ensuring successful submissions, global approvals, and alignment with health authorities (FDA, EMA, etc.) through strategic communication and regulatory excellence.
🧩 Main Responsibilities
1. Develop & Implement Regulatory Strategies
Design and execute global CMC regulatory strategies for development and marketed products.
Focus on chemical entities, biologics, and vaccine products.
Adapt and optimize strategies as needed across global markets.
2. Liaise with Regulatory Authorities
Serve as the primary contact for agencies such as US FDA and EMA.
Lead strategic discussions, negotiations, and submissions with global regulators.
Foster strong, collaborative relationships with health authorities.
3. Manage CMC Documentation & Submissions
Prepare, review, and approve regulatory CMC dossiers.
Ensure high-quality, compliant, and complete documentation.
Maintain submission accuracy and adherence to evolving regulations.
4. Cross-Functional Leadership
Collaborate closely with R&D, Manufacturing, and Quality teams.
Coordinate with GRA Regulatory Operations for efficient strategy execution.
Resolve CMC issues and ensure consistent alignment across departments.
5. Risk & Compliance Management
Identify and mitigate regulatory risks in CMC activities.
Communicate potential impacts and mitigation strategies to project teams.
Assess risk–benefit scenarios and support data-driven decisions.
6. Regulatory Intelligence & Policy Contribution
Monitor global regulatory trends and emerging guidelines.
Contribute to policy development and internal process improvements.
Anticipate regulatory paradigm shifts and advise leadership proactively.
🎓 Qualifications & Skills
Experience
4+ years in CMC regulatory affairs with contributions to filings and global strategy execution.
Experience responding to Health Authority queries and managing lifecycle submissions.
Regulatory Expertise
Strong understanding of pharmaceutical and vaccine development processes.
In-depth knowledge of CMC submission requirements across major markets.
Technical Knowledge
Familiar with manufacturing processes, quality systems, and regulatory compliance frameworks.
Proven ability to integrate scientific data into regulatory strategy.
Soft & Interpersonal Skills
Strong communication and leadership in a matrix environment.
Ability to manage multiple projects with agility and precision.
Excellent verbal and written English communication.
Education
Bachelor’s degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field).
Advanced degree preferred.
Work Mode
Hybrid role (60% on-site) with openness to international collaboration.
🌟 Why Choose Sanofi
Be part of an AI-powered, R&D-driven global biopharma leader.
Play a pivotal role in regulatory strategy and drug development.
Access structured career growth and leadership pathways.
Benefit from comprehensive health, wellness, and parental programs (14 weeks gender-neutral leave).
Work in a diverse, inclusive, and innovative culture that values every voice.
Enjoy flexibility, work–life balance, and opportunities for global mobility.
#Tags
#RegulatoryAffairs #CMC #GRA #PharmaceuticalJobs #Vaccines #Sanofi #Leadership #LI-Onsite #GD-SA
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