Regulatory Affairs Professional

3 days ago

Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000

We are seeking an experienced Regulatory Affairs professional to join our organization.

The successful candidate will be responsible for ensuring compliance and successful product approvals by applying subject matter expertise in Regulatory Affairs.

Key Responsibilities:

  • Lead the preparation and submission of product registration documents, progress reports, supplements, amendments, and periodic experience reports.
  • Ensure timely and accurate documentation in line with regulatory standards.
  • Interact with regulatory agencies to facilitate and expedite approvals of pending product registrations.
  • Serve as the primary regulatory point of contact throughout the product lifecycle.
  • Participate in product planning, regulatory strategy formulation, risk management, and Chemistry Manufacturing Control (CMC) processes.
  • Ensure timely approval and ongoing compliance for new drugs, biologics, or medical devices.
  • Act as the regulatory representative in interactions with marketing, research teams, and external agencies.
  • Advise internal teams on manufacturing changes, line extensions, technical labeling requirements, applicable regulations, and regulatory interpretations.

Qualifications & Skills:

  • Education: MBA or equivalent in a relevant discipline.
  • Experience: 3-5 years of professional experience in Regulatory Affairs within the pharmaceutical, biotechnology, or medical devices industry.
  • Strong understanding of relevant regulatory guidelines and submission requirements.
  • Excellent communication, analytical, and organizational skills.
  • Ability to work independently and manage multiple priorities under tight deadlines.

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