Regulatory Affairs Director

4 days ago


Karachi, Sindh, Pakistan beBee Careers Full time
About the Role: Head of Regulatory Affairs

This critical role is responsible for leading and elevating the regulatory function, ensuring compliant growth in local and international markets.

The ideal candidate will possess a blend of deep regulatory expertise and strong cross-functional influence, especially across manufacturing, quality, supply chain, and business leadership.

Key Responsibilities:

  1. Develop and implement end-to-end regulatory strategies and operations across all product categories and markets.
  2. Oversee registration, renewal, and variation submissions for global authorities.
  3. Ensure all dossiers (local and international) are compliant, audit-ready, and continuously updated.
  4. Collaborate with R&D, manufacturing, and quality teams to ensure regulatory readiness and alignment.
  5. Coordinate with international teams on regulatory submissions for export markets.
  6. Manage regulatory audits, inspections, and correspondence with authorities.
  7. Design and strengthen internal regulatory systems, SOPs, and document management tools.
  8. Stay ahead of evolving local and international regulatory frameworks.

Requirements:

  • 10+ years of experience in regulatory affairs within the pharmaceutical industry.
  • In-depth understanding of DRAP processes and documentation requirements.
  • Experience managing product lifecycles across domestic and export markets.
  • Proven ability to lead teams and influence cross-functionally across technical and commercial domains.
  • Strong documentation, compliance, and stakeholder management skills.

Benefits:

  • Opportunity to work in a dynamic environment with a chance to make a significant impact.
  • Potential for career growth and professional development.
  • A collaborative and supportive team culture.


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