Regulatory Affairs Executive

2 days ago

Doha, Baladīyat ad Dawḩah, Qatar Protectol Health Full time 90,000 - 120,000 per year

Key Responsibilities

  • Prepare accurate and timely responses to MOPH (Ministry of Public Health – Qatar) inquiries in coordination with relevant departments, ensuring compliance with applicable regulations and submission deadlines.
  • Review and analyze variations received from internal departments, determine their classification, assess required documents, and prepare variation submissions in line with MOPH regulatory guidelines.
  • Compile, validate, and submit CTD/eCTD dossiers for medicinal products, medical devices, and health supplements as per Qatar MOPH requirements.
  • Monitor and follow up on regulatory submissions, pricing applications, inquiries, renewals, and variation statuses with MOPH to ensure process continuity and timely approvals.
  • Ensure successful execution of the product registration plan by tracking milestones and coordinating with internal stakeholders to achieve regulatory objectives.
  • Maintain valid registration of all marketed products, ensuring that PILs, SmPCs, labels, and artworks are updated and compliant with Qatar regulations.
  • Act as the regulatory liaison for product life cycle activities, including post-approval changes, renewals, and regulatory updates to support product continuity in the Qatar market.
  • Stay updated on changes in Qatar's regulatory framework and provide strategic input to management on potential regulatory risks, impacts, or opportunities.
  • Develop and maintain strong working relationships with MOPH officials, regulatory consultants, and government representatives to facilitate smooth regulatory interactions.
  • Support internal and external audits by ensuring full readiness of regulatory documentation and compliance records.

Qualifications

  • Bachelor's or master's degree in pharmacy, Life Sciences, or a related field.
  • Minimum 1–4 years of experience in Regulatory Affairs within the pharmaceutical or healthcare sector, preferably with experience in the Qatar market or GCC region.
  • Strong knowledge of MOPH submission processes, regulations, and online portals used in Qatar.
  • Hands-on experience with CTD/eCTD compilation and publishing.
  • Proven track record in handling product registrations, variations, renewals, and regulatory compliance.
  • Prior experience in leading or mentoring a small team is an advantage.

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