PHARMAFull-time
Head Regulatory Diabetes and Rare Disease
MUMBAI (IN)ONSITEPOSTED: 9/18/2026
PHARMAFull-time
HIRING ORGANIZATIONSANOFIPharmaceuticals / Biotechnology
ROLE OVERVIEW
Lead Regulatory Affairs strategy for Sanofi's Diabetes and Rare Disease portfolio in India, enabling timely market authorization, launches and lifecycle management while maintaining regulatory compliance. Partner with global and local stakeholders, Indian regulatory authorities and business leadership, while leading and developing the local Regulatory Affairs team.
ROLE DEFINITION & RESPONSIBILITIES
- •Own Regulatory Affairs activities and provide strategic regulatory support to the India Business Unit
- •Develop and implement regulatory strategies for market authorization and product launches
- •Lead regulatory submissions and approval activities for new products
- •Partner with Global Regulatory Affairs on renewals, post-approval changes, CMC variations and labelling updates
- •Ensure packaging, labelling and product information remain aligned with regulatory approvals
- •Monitor emerging regulations and assess impact on marketed and pipeline products
- •Ensure promotional and communication materials comply with regulatory requirements
- •Manage the local Regulatory Affairs budget and represent the function in senior leadership forums
- •Maintain relationships with CDSCO, CDTL, CDL, NPPA, Ministry of Health and other authorities
- •Lead, coach and develop the local Regulatory Affairs team
Reporting Hierarchy: Reports to relevant senior business/regulatory leadership; leads and develops the local Regulatory Affairs team and partners with Business Units, Global Regulatory Affairs, Finance, Public Affairs and other cross-functional stakeholders
* 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 of people leadership or Regulatory Affairs leadership experience
- Strong practical knowledge of Indian drug and/or medical device regulations
- Experience with new product registrations, marketing authorizations and lifecycle management
- Experience with post-approval variations, renewals, labelling and regulatory compliance
- Experience interacting with Indian regulatory authorities
- Strong stakeholder management, communication and negotiation skills
PREFERRED QUALIFICATIONS
- •M.Pharm, M.Sc., Pharm.D. or equivalent qualification preferred
- •Experience partnering with Global Regulatory Affairs and cross-functional business stakeholders
- •Experience in promotional compliance, audits/inspections and emerging regulatory requirements
- •Experience leading and developing Regulatory Affairs teams
REQUIRED VERIFIED SKILLS
Indian regulatory affairs
CDSCO
CDTL
CDL
NPPA
Ministry of Health
regulatory strategy
market authorization
new product registration
lifecycle management
post-approval variations
CMC variations
renewals
labelling compliance
promotional compliance
regulatory submissions
regulatory risk assessment
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Health insurance, provident fund, paid leave and other standard employee benefits; exact benefits vary by location and employment terms
The source does not disclose salary or bonus/equity information. Compensation should be confirmed directly with Sanofi during recruitment.
ORGANIZATION CONTEXT & CULTURE
Sanofi is an R&D-driven biopharmaceutical company focused on developing medicines and vaccines and improving patient outcomes. Sanofi India is implementing a transformation strategy focused on growth, customer centricity and contemporary ways of working.
TEAM SIZE: 80,000+ employees globally
INDUSTRY: Pharmaceuticals / Biotechnology
Culture: The role emphasizes patient-focused innovation, strategic partnership, accountability, collaboration, empowerment and continuous development within a complex global and matrixed organization.
EXPECTED CAREER ROADMAP
Potential progression can include broader India Regulatory Affairs leadership, regional or global regulatory leadership, portfolio strategy and senior biopharmaceutical business-partner roles, depending on organizational opportunities and experience.
APPLICATION ADVISORY
Emphasize 12–15+ years of Regulatory Affairs experience, Indian regulatory expertise and leadership scope; highlight successful registrations, approvals and lifecycle-management programs; demonstrate relationships with CDSCO and other Indian authorities; quantify launches, submissions or compliance improvements; showcase strategic stakeholder management and people leadership; tailor the CV toward Diabetes and Rare Disease portfolio responsibilities.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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