R&D Global Regulatory Affairs CMC Lead
ROLE OVERVIEW
Sanofi’s Global Regulatory Affairs CMC & Device Organization seeks an R&D GRA CMC Lead in Hyderabad to shape regulatory strategies for pharmaceuticals, biologics, vaccines, and combination products. This senior role is central to Sanofi’s pipeline, bridging R&D, manufacturing, and health authorities such as the US FDA and EMA. The CMC Lead ensures dossiers meet global quality and compliance standards, accelerates approvals, and mitigates regulatory risks across the product lifecycle. As a strategic partner, the position influences cross-functional teams, regulatory policy, and digital innovation, including AI-enabled regulatory workflows. For experienced CMC professionals, this is a high-visibility opportunity to lead complex submissions, negotiate with regulators, and advance patient access to innovative therapies while growing within a world-class regulatory network.
ROLE DEFINITION & RESPONSIBILITIES
- •Develop and execute global CMC regulatory strategies for chemical entities, biological entities, vaccines, and drug-device combination products across development and marketed lifecycle.
- •Serve as primary liaison with US FDA, EMA, and other global health authorities; lead strategic negotiations and regulatory interactions.
- •Write, review, and approve CMC dossiers, CTAs, IND/IMPD, NDA/BLA/MAA modules, and lifecycle submissions.
- •Ensure documentation accuracy, completeness, and strict compliance with evolving global regulatory requirements and quality standards.
- •Lead cross-functional collaboration with R&D, manufacturing, supply, and GRA Operations to resolve CMC issues and ensure effective implementation of regulatory strategies.
- •Identify regulatory CMC risks and opportunities; develop mitigation plans and communicate risk/benefit implications to project teams and stakeholders.
- •Monitor Health Authority regulations, trends, and policy developments; contribute to regulatory science, advocacy, and digital/AI adoption initiatives.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- B.Pharm, M.Pharm, PharmD, MSc, PhD, or equivalent in pharmaceutical sciences, chemistry, biology, or related discipline.
- 8–12+ years in the pharmaceutical industry with strong, progressive CMC regulatory affairs expertise.
- Deep understanding of drug development, manufacturing processes, analytical testing, and quality systems.
- Proven experience preparing, reviewing, and submitting complex global regulatory dossiers (IND/CTA, NDA/BLA/MAA).
- Hands-on experience with combination drug/device products and comprehensive global regulatory requirements.
- Demonstrated leadership in matrix environments and proven ability to influence cross-functional stakeholders.
- Familiarity with AI applications in regulatory affairs and electronic document management systems (Veeva Vault, Plai).
PREFERRED QUALIFICATIONS
- •Regulatory Policy & Advocacy
- •Digital Adoption & Automation
- •People Leadership/Mentoring
- •Health Authority Negotiation Experience
- •Vaccine/Biologics CMC Expertise
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
Sanofi is a global biopharmaceutical company dedicated to human health. It researches, develops, manufactures, and markets innovative therapeutic solutions with a focus on specialty care, vaccines, general medicines, and consumer healthcare products. The company aims to prevent and treat a wide range of diseases worldwide.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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