Regulatory Affairs Director

4 days ago


Mumbai, Maharashtra, India Lifelancer Full time
About Lifelancer

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT.

Salary Information

The estimated annual salary for this role is ₹1,500,000 - ₹2,250,000.

Job Description

This experienced professional will work under limited supervision to apply subject matter knowledge in the area of Regulatory Affairs.

  • Direct development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
  • Interact with regulatory agencies to expedite approval of pending registrations.
  • Act as a regulatory liaison throughout the product lifecycle.
  • Participate in product plan development, regulatory strategy, risk management, and chemistry manufacturing control (CMC).
  • Evaluate new drugs, biologics, or medical devices and ensure continued approval of marketed products.
  • Represent regulatory affairs to marketing, research teams, and regulatory agencies.
Key Responsibilities

Main Responsibilities:

  • Develop and maintain knowledge of global regulatory requirements.
  • Maintain compliance with regulatory standards.
  • Collaborate with cross-functional teams to address regulatory issues.
  • Analyze data to inform regulatory strategies.
Requirements

To be successful in this role, you should have an Associate Degree (± 13 years) and relevant experience in Regulatory Affairs.



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