Opportunity for Regulatory Affairs Manager at Sanofi-Apply before 30th May 2024


Website Sanofi

About Sanofi

Sanofi is a multinational pharmaceutical company headquartered in Paris, France. It’s one of the largest pharmaceutical companies in the world, with a focus on research, development, manufacturing, and marketing of pharmaceutical products. Sanofi produces medications in several therapeutic areas, including diabetes, cardiovascular diseases, vaccines, oncology, and rare diseases. Additionally, it has a significant presence in consumer healthcare products.

Regulatory Affairs Manager

Job Description

The Regulatory Affairs Manager assumes a pivotal scientific leadership role, spearheading regulatory activities within the India/Sri Lanka/Nepal/Maldives markets. This position devises regulatory strategies and oversees submissions for new products across Rx/OTC/Food supplement categories, supporting both existing and emerging portfolios. Additionally, the Regulatory Manager ensures regulatory compliance, oversees data management, and champions a portfolio approach for scientific value creation, all while adhering to established timelines.

Key Responsibilities at Sanofi

  • Regulatory Strategies: Formulate regulatory strategies to accelerate product innovation and brand growth within the designated markets.
  • Compliance Oversight: Ensure compliance of the existing Consumer Healthcare (CHC) portfolio and facilitate timely approvals for all marketing authorizations.
  • Submission Quality: Deliver high-quality regulatory submissions within agreed-upon timelines, collaborating closely with internal and external stakeholders.
  • Cross-functional Collaboration: Foster effective communication and collaboration with Medical, Marketing, and business teams to achieve strategic objectives.
  • Continuous Learning: Maintain and enhance regulatory skills through ongoing training and knowledge sharing with colleagues.

Main Responsibilities at Sanofi

  1. Regulatory Compliance: Ensure adherence to product packaging standards, update Marketing Authorizations as per corporate requirements, and uphold regulatory SOPs.
  2. Portfolio Management: Manage local maintenance activities, prepare dossiers for new product developments, and facilitate OTC switches.
  3. Risk Management: Coordinate local health authority approvals for risk management plans and ensure the availability of approved product information.
  4. Regulatory Database: Lead compliance efforts for regulatory registration databases and track submissions in local and global databases.

Candidate Profile Required at Sanofi

  • Qualifications: Degree in Pharmacy or relevant scientific field.
  • Experience: 3-5 years in Regulatory Affairs, with a focus on the India and South Asia markets.
  • Industry Knowledge: Familiarity with consumer healthcare and pharmaceutical industries, including regulatory frameworks and R&D processes.
  • Regulatory Expertise: Proficiency in local regulatory requirements and the ability to assess their impact on product development and submission strategies.

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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To apply for this job please visit en.jobs.sanofi.com.