Head of Regulatory Affairs

3 weeks ago

Karachi, Sindh, Pakistan The Catalyst Group Full time

Location: Head Office, Karachi

Reports to: Executive Director, Technical Operations

The Catalyst Group is hiring a Head of Regulatory Affairs for its client, International Brands Limited (IBL), a leading business group.

About The Role

Were looking for a detail-driven and forward-looking Head of Regulatory Affairs to lead and elevate the regulatory function at The Searle Company Limited. This role is central to enabling compliant growth both in local and international markets by ensuring timely product registrations, smooth regulatory inspections, and effective lifecycle management of all dossiers.

The ideal candidate brings a balance of deep regulatory expertise and strong cross-functional influence particularly across manufacturing, quality, supply chain, and business leadership.

Key Responsibilities

  • Lead end-to-end regulatory strategy and operations across all product categories and markets
  • Oversee registration, renewal, and variation submissions for DRAP and relevant global authorities
  • Ensure all dossiers (local and international) are compliant, audit-ready, and continuously updated
  • Partner closely with R&D, manufacturing, and quality teams to ensure regulatory readiness and alignment
  • Coordinate with international teams or partners on regulatory submissions for export markets
  • Manage regulatory audits, inspections, and correspondence with authorities ensuring transparent and timely engagement
  • Build and strengthen internal regulatory systems, SOPs, and document management tools
  • Stay ahead of evolving local and international regulatory frameworks and lead internal adaptations
  • Support regulatory inputs into product development, new launches, and business expansions

What You'll Bring
  • 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 both 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
  • Familiarity with global regulatory frameworks (e.g., WHO PQ, GCC, ASEAN, etc.) is a plus
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