Sanofi Require Head Regulatory Diabetes and Rare Disease

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients’ daily life, wherever they live and enabling them to enjoy a healthier life.

Post : Head Regulatory Diabetes and Rare Disease

Job Description
• Own Regulatory Affairs activities and provide strategic regulatory support to the respective Business Unit in India.
• Develop and implement effective regulatory strategies and pathways for Sanofi products to enable timely market authorization and product launches.
• Lead regulatory submissions and approval activities for new products in alignment with business and patient needs.
• Partner with Global Regulatory Affairs and other internal stakeholders on renewals, post-approval changes, CMC variations, labelling updates and other lifecycle management activities.
• Ensure product packaging, labelling and associated product information are aligned with current regulatory approvals and licenses and are implemented in a timely manner.
• Monitor emerging regulatory requirements and assess their potential impact on marketed and pipeline products.
• Provide Regulatory Affairs input into product portfolio optimization, product pruning and other strategic business decisions.
• Ensure regulatory compliance of promotional and communication materials.
• Ensure local implementation of Global Regulatory Affairs mandatory SOPs, policies and training requirements.
• Manage the local Regulatory Affairs budget in collaboration with Finance.
• Represent Regulatory Affairs in relevant Business Unit and senior leadership forums, providing strategic regulatory advice and risk assessment.
• Establish and maintain effective relationships with Indian regulatory authorities, including CDSCO, CDTL, CDL, NPPA, Ministry of Health and other relevant government bodies, as required.
• Contribute to shaping the regulatory environment in India through active participation in relevant industry associations and collaboration with Public Affairs.
• Lead, coach and develop the local Regulatory Affairs team, fostering a culture of accountability, collaboration and continuous development.

Candidate Profile
• M.Pharm, M.Sc., Pharm.D. or equivalent qualification preferred.
• Strong understanding of Indian regulatory landscape and regulatory processes.
• Strategic thinking with strong business acumen.
• Excellent stakeholder management and influencing skills.
• Strong communication and negotiation skills.
• Ability to operate effectively in a complex, matrixed and global organization.
• Strong leadership and people development capabilities.
• Ability to manage multiple priorities while ensuring regulatory compliance and business continuity.

• 12–15+ years of relevant experience in Regulatory Affairs within the pharmaceutical, healthcare or related industry.
• At least 2–3 years of experience in a people leadership or Regulatory Affairs leadership role.
• Strong knowledge and practical experience of Indian regulatory requirements for drugs and/or medical devices.
• Demonstrated experience in new product registrations, marketing authorizations and product lifecycle management.
• Experience managing post-approval variations, renewals, labelling and regulatory compliance activities.
• Experience interacting with Indian regulatory authorities and government bodies.
• Strong experience partnering with Global Regulatory Affairs and cross-functional business stakeholders.
• Demonstrated ability to translate regulatory requirements into practical business strategies and recommendations.
• Experience in regulatory strategy, promotional compliance, audits/inspections and emerging regulatory requirements.
• Experience in leading and developing Regulatory Affairs teams.

Additional Information
Experience : 2–3 years
Qualification : M.Pharm, M.Sc., Pharm.D
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Diabetes and Rare Disease
End Date : 10th November 2026