Regulatory Affairs Manager Position Available

2 days ago


Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

Job Title: Regulatory Affairs Manager

The ideal candidate for this role will be responsible for ensuring that all regulatory submissions are compliant with the appropriate regulatory guidelines. This will involve working closely with internal stakeholders to assess post-approval product changes and determine the best global filing strategy.

Key Responsibilities:

  • Manage the assembly, compilation, submission, and electronic publishing of documentation for product compliance, registration, and life cycle maintenance.
  • Support regulatory and broader development teams on strategic projects, including gap analyses, meetings with regulatory authorities, product development, and review.
  • Evaluate business opportunities and perform regulatory due diligence for in-licensing and product acquisition for assigned regions.
  • Maintain up-to-date knowledge of data requirements, applicable SOPs, policies, regulations, guidelines, and industry standards.

Qualifications:

  • Master's degree in a relevant field (Regulatory Affairs certification is preferred).
  • Minimum of 8-10 years of experience in a pharmaceutical regulatory affairs department.
  • Experience in leading dossier submissions to LATAM/ROW markets and post-approval variations.

Requirements:

  • Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders.
  • Expert knowledge and proficiency at interpreting regulatory guidelines.
  • Strong analytical, conceptual, problem-solving, and decision-making abilities.
  • Effective collaboration skills.
  • Proactive, with a strong ability to learn and adapt.


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