Research & Development Regulatory Affairs Chemistry, Manufacturing and Controls Team Lead

R&D GRA CMC Team Lead

Job Title: R&D GRA CMC Team Lead

• Location: Hyderabad (Hybrid)

• Level: L3-2

About the job

Our Team:

​​​​​​The Global Regulatory Affairs (GRA) CMC & Device Organization 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.​ 

 Main responsibilities:

Strategic Leadership & Team Development 

Provide oversight and leadership of a specialist sub-team within the CMC regulatory organization 

Set clear expectations and performance objectives aligned with GRA goals

Foster an environment that promotes Taking the Lead behaviors and GRA Values 

Global Regulatory Strategy Oversight 

Oversee the development of global regulatory CMC strategies and risk assessments for development projects and marketed products 

Ensure appropriate strategies for major CMC activities with critical regulatory and financial impact 

Build and maintain internal/external relationships to achieve regulatory outcomes 

Matrix Management Excellence 

Enable effective matrix management between line organization and project Teams.

Establish clear roles and responsibilities between CMC Lead and Project Leads.

Coordinate with Project Leads on long-term resource planning 

Regulatory Intelligence Leadership

Interpret global regulations and implement them within the team's work.

Identify and communicate regulatory paradigm shifts that impact the company.

Contribute knowledge to GRA Regulatory Science and Policy activities 

Performance Management & Talent Development 

Conduct regular performance evaluations and career development discussions

Identify skill gaps and create development opportunities through strategic project assignments

Work with Project Leads to identify and develop high-potential team members 

Portfolio Management & Resource Optimization

Align team structure and capabilities with project portfolio needs.

Ensure balanced workload distribution among team members.

Collaborate with Project Leads to optimize resource allocation across projects 

About you

List here ideally the must-haves criteria to be successful on the role. Don’t forget: the less criteria you will request, the more diverse candidates you will get in the pool.

• Experience: 15-17 Years , strong experience in pharmaceutical, CMC regulatory strategy experience, Expert-level understanding of CMC regulatory requirements across multiple regions

• Advanced knowledge of drug development, manufacturing, and testing processes, Strong understanding of AI and its applications in regulatory affairs, Exceptional leadership and team development abilities, Strategic thinking and ability to drive organizational change, Advanced negotiation and influencing skills with global regulatory bodies (e.g., FDA, EMA). Ability to manage complex, multi-stakeholder relationships & Proven ability to make high-impact decisions in ambiguous situations

• Soft skills: Communication skills, Stakeholder management, Adaptability & flexibility, Critical thinking, Problem solving, Teamwork & collaboration, Time management, Emotional intelligence (EQ), Compliance & quality mindset, Proactive ownership & Presentation skills

• Technical skills: Strategic Thinking, Results-Oriented, People Leadership, Influencing, Others Regulatory Strategies, Product Registrations, Risk Management, Digital Adoption, Stakeholder Management & Advanced proficiency in MS Office Suite & Electronic document management systems (Veeva vault, Plai)

• Languages: English

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Experience Level

Senior Level