Scientific & Regulatory Assessor – Clinical, Non‑Clinical & Biologicals

About the role

Emirates Drug Establishment (EDE) is expanding its regulatory team in the United Arab Emirates. We are looking for experienced professionals to join as Scientific & Regulatory Assessors across three specialised streams: Clinical, Non‑Clinical, and Biologicals/ATMP.

Key responsibilities

• Independently evaluate complex scientific data and regulatory dossiers.
• Perform benefit‑risk assessments for clinical pharmacology submissions.
• Conduct non‑clinical safety assessments, including toxicology, reproductive toxicity and genotoxicity.
• Review biological product and advanced therapy dossiers, covering characterization, immunogenicity and long‑term safety.
• Provide clear, evidence‑based recommendations to regulatory authorities and internal stakeholders.

Required profile

• 5–10 years of relevant experience in the respective area.
• Advanced degree (MD, PharmD, PhD, DVM, MSc) in a related discipline.
• Proven experience in regulatory assessment or product development.
• Ability to work autonomously and communicate scientific findings effectively.

Required skills

• Clinical pharmacology, PK/PD, dose selection, study design, benefit‑risk assessment.
• Pharmacology, PK/TK, toxicology, safety pharmacology, reproductive toxicity, genotoxicity, carcinogenicity.
• Biotechnology, product characterization, manufacturing, potency, comparability, immunogenicity, cell therapy, gene therapy, vector development.

What we offer

• On‑site work in a state‑of‑the‑art facility.
• Opportunity to influence regulatory decisions for innovative therapies.
• Collaborative environment with leading experts in drug assessment.