Head Regulatory Affairs

Job Title: Head Regulatory Affairs

Location: Mumbai

About The Job

At Sanofi, Regulatory Affairs plays a critical role as a strategic business partner, enabling the business to achieve its objectives while ensuring compliance with applicable regulatory requirements.

The Regulatory Affairs team is responsible for developing and implementing regulatory strategies for Sanofi products in India, supporting new product launches, maintaining existing marketing authorizations and ensuring business continuity throughout the product lifecycle.

The role requires strong expertise in Indian drug and device regulations, with the ability to partner effectively with Business Units, Global Regulatory Affairs and other cross-functional teams.

About Sanofi

Sanofi is an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Now, with its Take the Lead Strategy the objective is to make a greater impact on patients, healthcare systems, and society at large scale. This means (i) pioneering an innovative pipeline and executing transformative launches at scale to bring life-changing new medicines and vaccines to more people, more quickly (ii) modernizing and deploying resources with agility (iii) building a sustainable business that tackles the most urgent healthcare, environmental, and societal challenges of our time

Sanofi India is implementing an ambitious transformation plan aligned with our Take the Lead Strategy and Values, with 3 main objectives (i) achieve our target growth for the Diabetes portfolio in Public and Private market (ii) Foster empowerment and autonomy at customer level to create a customer centricity approach (iii) Implement contemporary ways of working for better efficiency

Main Responsibilities

• 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.
• About You
• Experience
• 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.
  
  

Education

M.Pharm, M.Sc., Pharm.D. or equivalent qualification preferred.

Skills & Competencies

• 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.