R&D GRA CMC Lead
About this opportunity
Job title: R&D GRA CMC Lead
Location: Hyderabad
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:
Develop and implement global regulatory CMC strategies, create strategies for development and marketed products, focus on chemical entities, biological entities, and/or vaccine products, execute and adapt strategies as needed
Serve as the primary point of contact for regulatory authorities, Act as direct liaison with agencies like US FDA and EMA, Develop positive relationships with regulators ,Support strategic negotiations with worldwide Regulatory Health Authorities
Manage CMC documentation and submissions, Write, prepare, review, and approve regulatory CMC dossiers, ensure dossiers meet quality standards, comply with regulatory requirements, Maintain documentation accuracy and completeness
Lead cross-functional collaboration, work closely with R&D Functions, Collaborate with Manufacturing & Supply Functions, Coordinate with GRA Regulatory Operations, ensure effective implementation of regulatory strategies, Facilitate resolution of CMC issues
Identify and manage regulatory risks, assess regulatory CMC opportunities and risks, develop risk mitigation strategies, communicate implications to project teams, Articulate risk/benefit components to stakeholders
Contribute to regulatory science and policy activities, monitor local and international Health Authority regulations and guidelines, participate in the review process for new regulations, anticipate potential regulatory paradigm shifts, Track and communicate current Health Authority thinking and trends
About you
Experience in the pharmaceutical industry with strong expertise in CMC Regulatory Affairs.
Strong understanding of drug development, manufacturing, and testing processes, Good understanding of Artificial Intelligence applications in regulatory affairs
Experience with combination (drug/device) products Advanced proficiency in regulatory documentation preparation
Comprehensive knowledge of global regulatory requirements, Experience with complex regulatory submissions
Demonstrated leadership in matrix environment , Proven ability to influence cross-functional stakeholders
Experience managing multiple high-priority products simultaneously Advanced communication skills with ability to persuade and negotiate
Strong mentoring capabilities Strategic thinking and decision-making abilities
Advanced communication skills with ability to persuade and negotiate 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)
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, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !
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.