Associate, Regulatory Affairs

About the role

Hikma Pharmaceuticals is seeking a motivated Associate in Regulatory Affairs to join its Casablanca team. You will work in a collaborative environment that values innovation, caring, and teamwork while supporting the development and approval of pharmaceutical products.

Key responsibilities

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

Required profile

• Degree in Pharmacy or a Master’s degree in Pharmaceutical Quality Assurance, Regulatory Affairs, or an equivalent scientific field.
• Minimum of 2 years of professional experience in Regulatory Affairs.
• Demonstrated autonomy, proactivity, and strong sense of responsibility.
• Strong analytical skills with high attention to detail.
• Flexibility, adaptability, and ability to work effectively in a team.

Required skills