PHARMAFull-time
Head Regulatory Affairs
By Admin · Regulatory Affairs
MUMBAI (IN)ONSITEPOSTED: 9/11/2026
PHARMAFull-time
HIRING ORGANIZATIONSANOFIPharmaceuticals / Biotechnology
ROLE OVERVIEW
Lead Sanofi's Regulatory Affairs strategy in India, ensuring regulatory compliance, successful product approvals and launches, and effective lifecycle management while partnering with business, global regulatory and government stakeholders.
ROLE DEFINITION & RESPONSIBILITIES
- •Own Regulatory Affairs activities and provide strategic regulatory support to the Business Unit
- •Develop and implement regulatory strategies and pathways for Sanofi products
- •Lead regulatory submissions and approval activities for new products
- •Partner with Global Regulatory Affairs and cross-functional teams on renewals, post-approval changes, CMC variations and labelling updates
- •Ensure packaging, labelling and product information comply with current approvals and licenses
- •Monitor emerging regulatory requirements and assess impact on products
- •Provide regulatory input into portfolio optimization and strategic decisions
- •Lead, coach and develop the local Regulatory Affairs team and maintain relationships with Indian regulatory authorities
Reporting Hierarchy: Reports to relevant senior Business Unit/Regulatory leadership; Team leadership responsibility for the local Regulatory Affairs function
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- 12–15+ years of relevant Regulatory Affairs experience in pharmaceutical, healthcare or related industry
- 2–3+ years in a people leadership or Regulatory Affairs leadership role
- Strong knowledge of Indian regulatory requirements for drugs and/or medical devices
- Experience in new product registrations, marketing authorizations and lifecycle management
- Experience with post-approval variations, renewals, labelling and regulatory compliance
- Experience interacting with Indian regulatory authorities and government bodies
PREFERRED QUALIFICATIONS
- •M.Pharm, M.Sc., Pharm.D. or equivalent qualification
- •Experience with promotional compliance, audits/inspections and emerging regulations
- •Strong global and cross-functional stakeholder management experience
- •Experience participating in industry associations or regulatory-policy initiatives
REQUIRED VERIFIED SKILLS
Indian regulatory affairs
CDSCO
CDTL
CDL
NPPA
Ministry of Health
regulatory strategy
new product registration
marketing authorization
product lifecycle management
post-approval variations
renewals
labelling compliance
CMC variations
promotional compliance
regulatory submissions
audits
inspections
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Standard corporate benefits and employee support programs; specific benefits are not stated in the source posting.
The source posting does not disclose a salary range, bonus or equity package. Compensation should therefore be confirmed directly with Sanofi during the recruitment process.
ORGANIZATION CONTEXT & CULTURE
Sanofi is an R&D-driven, AI-powered biopharmaceutical company focused on developing medicines and vaccines and improving patient outcomes. Sanofi India is implementing a transformation plan focused on portfolio growth, customer-centricity and modern ways of working.
TEAM SIZE: 100,000+ employees globally
INDUSTRY: Pharmaceuticals / Biotechnology
Culture: Patient-focused, science-driven and collaborative environment operating across a complex global matrix, with emphasis on innovation, accountability, inclusion and continuous development.
EXPECTED CAREER ROADMAP
Potential progression can include broader country or regional Regulatory Affairs leadership, global regulatory strategy roles, portfolio leadership and senior pharmaceutical executive positions.
APPLICATION ADVISORY
Highlight 12–15+ years of Regulatory Affairs experience; demonstrate hands-on knowledge of Indian drug/device regulations and CDSCO processes; showcase successful product registrations, launches and lifecycle-management work; quantify leadership and team-development impact; emphasize experience with global regulatory stakeholders and senior business leadership; prepare examples of regulatory risk assessment and strategic decision-making.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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