Leading Regulatory Affairs Manager

21 hours ago

Mumbai, Maharashtra, India beBeeRegulatoryAffairsManager Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Regulatory Affairs Manager Job Opportunity

Job Overview:

The Regulatory Affairs Manager is responsible for overseeing the portfolio of pharmaceutical products in the USA market. They will be responsible for authoring and reviewing submissions for dissemination to Health Authorities, country distributors or external partners.

Key Responsibilities:
  • Manage the assembly, compilation, submission and electronic publishing (if required) 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 region.

Required Skills and Qualifications:

  • Master's in Pharmacy degree with full-time experience in a pharmaceutical regulatory affairs department.
  • Minimum 8-10 years of experience in leading dossier submission to Latam/ROW markets and post-approval variations.
  • Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders.

Benefits:

  • Expert knowledge and proficiency at interpreting regulatory guidelines.
  • Ability to draft the CMC section of dossier.
  • Strong analytical, conceptual, problem-solving, and decision-making abilities.

Others:

  • Maintain up-to-date knowledge of data requirements, applicable SOPs, policies, regulations, guidelines, and industry standards.
  • Review and interpret pertinent regulations and guidelines to develop proactive solutions to regulatory issues and challenges.

Keyword: RegulatoryAffairsManager

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