Hyderabad Full time R2863517 **R&D; GRA CMC Team Lead** **_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, 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.?_ _M_ **_ain 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 setting 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_** + _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_ + _Communication skills, Stakeholder management, Adaptability & flexibility, Critical thinking, Problem solving, Teamwork & collaboration, Time management, Emotional intelligence EQ, Compliance & quality mindset, Proactive ownership & Presentation 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_ **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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t;=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! We are an R&D; driven, AI-powered biopharma company committed to improving people's lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people's lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) Start a career that makes a difference. Reinvention is in our DNA. It's what drove our evolution from a small French enterprise to one of the world's leading biopharma companies. Whether it's using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people's lives.

📌 R&D GRA CMC Team Lead (Hyderabad)
🏢 Sanofi Group
📍 Hyderabad