R&D GRA CMC Team Lead
About this opportunity
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 !
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 305 comparable Regulatory Affairs roles across 67 biopharma companies.
Salary context
85 of 305 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 305 comparable roles
+ 31 more countries
Seniority mix
261 of 305 peers have a known seniority level
Therapeutic area mix
33 of 305 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.