Regulatory Affairs Specialist

11 hours ago

Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 30,00,000
Job Overview

The Manager of Regulatory Affairs will be a specialist professional with comprehensive knowledge in the area of regulatory affairs.

Main Responsibilities:
  • Develop and manage product registration submissions, progress reports, supplements, amendments, or periodic experience reports as a highly experienced and knowledgeable resource within the organization.
  • Facilitate interaction with regulatory agencies to expedite approval of pending registrations.
  • Act as the primary liaison for regulatory matters throughout the product lifecycle.
  • Participate in product plan development and implementation, regulatory strategy, risk management, and chemistry manufacturing control (CMC).
  • E nsure timely approval of new drugs, biologics, or medical devices and continued approval of marketed products.
  • Represent regulatory interests to marketing, research teams, and regulatory agencies.
  • Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations.
Qualifications:
  • Bachelor's degree in life sciences or a related field is required.
  • A minimum of 7 years of experience in regulatory affairs is preferred.

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