Regulatory Affairs CMC Team Lead
ROLE OVERVIEW
This R&D GRA CMC Team Lead role at Sanofi in Hyderabad is a senior regulatory affairs leadership position within the Global Regulatory Affairs CMC & Device Organization. The incumbent will shape global Chemistry, Manufacturing, and Controls strategies for pharmaceuticals, biologics, vaccines, and combination products, directly influencing approval timelines and lifecycle management. As a critical bridge between technical development, manufacturing, and health authorities, this role ensures Sanofi's innovative therapies reach patients with speed and compliance. The position offers exceptional exposure to FDA, EMA, and other global regulators, matrixed project teams, and cutting-edge digital regulatory tools such as Veeva Vault. For regulatory professionals seeking to lead strategy, mentor specialists, and drive organizational change in a world-class biopharma environment, this is a compelling career step with significant influence on Sanofi's commercial and clinical pipeline.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead a specialist CMC regulatory sub-team, setting expectations, performance objectives, and development plans aligned with GRA goals.
- •Oversee global regulatory CMC strategies and risk assessments for development projects and marketed products across multiple regions.
- •Ensure major CMC activities with critical regulatory and financial impact are executed with appropriate strategies and documentation.
- •Build and maintain internal and external relationships with health authorities, partners, and cross-functional stakeholders to achieve approvals.
- •Enable effective matrix management between line organization and project teams, clarifying roles between CMC Leads and Project Leads.
- •Interpret global regulations, communicate regulatory paradigm shifts, and contribute to GRA Regulatory Science and Policy initiatives.
- •Conduct performance reviews, identify skill gaps, and create growth opportunities through strategic project assignments and talent development.
- •Align team structure and capabilities with portfolio needs, balancing workload and optimizing resource allocation with Project Leads.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Life Sciences, or related field; advanced degree preferred.
- 10+ years of pharmaceutical regulatory affairs experience, with substantial CMC regulatory strategy expertise across multiple regions.
- Expert-level knowledge of CMC regulatory requirements, drug development, manufacturing, and testing processes.
- Proven leadership experience managing specialist teams and developing talent in a matrixed global environment.
- Strong understanding of AI applications in regulatory affairs and digital tools such as Veeva Vault and Plai.
- Demonstrated negotiation and influencing skills with global regulatory bodies including FDA and EMA.
- Experience making high-impact decisions in ambiguous situations and managing complex multi-stakeholder relationships.
PREFERRED QUALIFICATIONS
- •Experience with biologics, vaccines, or combination products
- •Regulatory Science & Policy contributions
- •Digital adoption and regulatory automation
- •People leadership in global teams
- •Advanced degree (PhD, PharmD, or MSc)
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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