Regulatory Affairs Specialist

Key Responsibilities

• Manage Product Registrations: Prepare, submit, and track regulatory applications with UAE authorities to achieve timely approvals for products and licenses.
• Monitor Regulatory Changes: Stay current with local federal and Dubai‑specific regulations, assess impact, and update internal teams to ensure continued compliance.
• Compile Regulatory Dossiers: Collect required data, prepare submission documents, and organise files to meet authority standards and support applications.
• Liaise with Authorities: Communicate with government regulators to resolve questions, provide additional information, and support the approval process.
• Coordinate Across Teams: Work with quality, supply chain, marketing, and cross‑functional teams to align regulatory strategy and requirements.
• Compliance & Labeling Support: Ensure product labeling, packaging, and promotional materials meet UAE regulatory and authority expectations.
• Maintain Records & Reports: Keep accurate regulatory records, track submission progress, and prepare status reports for internal review.

Requirements

• Experience: 3–5+ years handling regulatory affairs in pharmaceuticals, medical devices, FMCG, or related sectors.
• Education: Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or related field.
• Technical Competence: Strong knowledge of regulatory systems, dossier preparation, and submission requirements in UAE.
• Project Controls: Ability to manage timelines, multiple filings, and regulatory milestones efficiently.
• Leadership: Clear communicator who supports internal teams and coordinates with external stakeholders.
  
• Commercial Acumen: Understands business impact of regulatory timelines and compliance on product strategy.