Regulatory Affairs Specialist

1 day ago

Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 28,00,000 - ₹ 35,00,000
Regulatory Affairs Expert Role

Main Objectives of the Position:

A highly skilled and knowledgeable professional contributor with in-depth knowledge in Regulatory Affairs. The position demands executing complex or specialized projects, adapting precedent, and developing innovative solutions to overcome traditional approaches.

Key Responsibilities:

  • Leads the development of product registration submissions, progress reports, supplements, amendments, and periodic experience reports.
  • Negotiates with regulatory agencies to expedite approval of pending registrations.
  • Serves as a regulatory liaison throughout the product lifecycle.
  • Participates in product plan development and implementation, regulatory strategy, risk management, and chemistry manufacturing control (CMC).
  • Ensures timely approval of new drugs, biologics, or medical devices and continued approval of marketed products.
  • Represents the organization as a regulatory representative to marketing, research teams, and regulatory agencies.
  • Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations.

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