Associate, Regulatory Affairs

About the role

Hikma Pharmaceuticals is seeking a Regulatory Affairs Associate to support the preparation, submission, and management of regulatory dossiers for pharmaceutical and parapharmaceutical products. The role works within a collaborative environment, interacting with R&D, Marketing, Quality, Production, and Supply Chain teams.

Key responsibilities

• Review and ensure compliance of regulatory dossiers before submission.
• Prepare, compile, and manage dossiers for Marketing Authorization Applications, renewals, and variations.
• Follow up on submitted dossiers throughout the evaluation process until approval.
• Collaborate with cross‑functional teams including R&D, Marketing, Quality, Production, and Supply Chain.
• Review and approve promotional materials from a regulatory perspective.
• Prepare and manage regulatory dossiers related to parapharmaceutical products.

Required profile

• Degree in Pharmacy, or a Master’s in Pharmaceutical Quality Assurance, Regulatory Affairs, or a related scientific field.
• Minimum of 2 years professional experience in Regulatory Affairs.
• Strong analytical skills, attention to detail, and ability to work autonomously.
• Flexibility, adaptability, and a collaborative team spirit.