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Leading Regulatory Expert

2 weeks ago

Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Regulatory Affairs Manager

Our organization seeks a seasoned Regulatory Affairs professional to spearhead regulatory projects, develop innovative compliance strategies, and ensure timely product approvals.

Key Responsibilities:

  • Prepare and submit product registration dossiers, supplements, amendments, progress reports, and periodic experience reports.
  • Interact with regulatory agencies to expedite product approvals.
  • Serve as a regulatory liaison throughout the product lifecycle, ensuring adherence to global and local regulations.
  • Contribute to product planning and implementation, including regulatory strategy, risk management, and CMC.
  • Ensure timely approval of new drugs, biologics, or medical devices, and continued approval of marketed products.
  • Advise cross-functional teams on regulatory requirements, technical labeling, line extensions, and interpretation of applicable regulations.

Requirements:

  • Bachelor's or Master's degree in a relevant field.
  • Minimum 7 years of experience in Regulatory Affairs, with expertise in submissions, regulatory strategy, and agency interactions.
  • Strong understanding of global and local regulatory guidelines (e.g., FDA, EMA, CDSCO).
  • Experience in drug development, biologics, or medical devices preferred.

Skills & Competencies:

  • In-depth knowledge of regulatory requirements and processes.
  • Excellent project management, analytical, and problem-solving skills.
  • Strong written and verbal communication skills for effective interactions with regulatory authorities and internal stakeholders.