Job Opportunity at Sanofi: Regulatory Affairs Manager

About Sanofi

Sanofi is dedicated to building a healthier, more resilient world by discovering, developing, and delivering medicines and vaccines to millions of people worldwide.

Position: Regulatory Affairs Manager

Job Description

The Regulatory Affairs Manager plays a pivotal role in leading regulatory activities in the India/Srilanka/Nepal/Maldives market. This role involves providing regulatory strategies, managing regulatory submissions for new products across various categories (Rx/OTC/Food supplements), ensuring compliance, and optimizing the portfolio for value creation.


  1. Regulatory Compliance:
    • Ensure compliance of product packaging and associated information with current product licenses.
    • Update Marketing Authorizations in line with Corporate requirements.
    • Ensure adherence to SOPs, quality, and compliance with local regulatory activities.
    • Stay updated with new regulatory requirements and assess their impact on existing products.
    • Review and approve promotional and non-promotional materials for compliance with local regulations.
  2. Portfolio Management and Optimization:
    • Support local maintenance activities and ensure compliance with the marketed product portfolio.
    • Prepare local dossiers for products under development and territory extensions.
    • Provide regulatory input for product portfolio optimization strategies.
  3. Drug & Food Supplements Development and Risk Management:
    • Provide regulatory inputs for new drug development and risk management plans.
    • Coordinate local health authority approval and implementation of risk management plans.
    • Lead the compliance of the regulatory registration database.

Candidate Profile

  • A degree in Pharmacy or Science is desirable.
  • Experience: 3-5 years in Regulatory Affairs, including managing the India and South Asia markets.
  • Good understanding of the consumer healthcare and pharmaceutical industry.
  • Knowledge of local regulations and Health Authorities’ requirements.
  • Strong communication and leadership skills.

Additional Information

  • Experience: 3-5 years
  • Qualification: Degree in Pharmacy or Science
  • Location: Mumbai, India
  • Industry Type: Pharma/ Healthcare/ Clinical research
  • Functional Area: Regulatory Affairs
  • End Date: 30th May 2024

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