Regulatory Affairs Officer

About the role

Hikma Pharmaceuticals, a leading generic and specialty drug manufacturer with over 45 years of experience, is seeking a Regulatory Affairs Officer to join its team in Sidi Thabet, Tunisia. The role supports product registration, renewal and post‑approval activities, ensuring compliance with local health authorities.

Key responsibilities

• Prepare, review and maintain regulatory dossiers and supporting documentation in accordance with applicable requirements.
• Manage regulatory activities for new product registrations, renewals, variations and other post‑approval submissions.
• Prepare and submit regulatory applications to health authorities and track their progress.
• Coordinate responses to queries and requests for additional information from regulatory agencies.
• Ensure product documentation and regulatory records remain accurate, complete and up‑to‑date.
• Monitor regulatory changes and assess their impact on products and business activities.
• Collaborate with internal functions such as Quality, Medical, Supply Chain and Marketing to align regulatory strategies.

Required profile

• University degree in Pharmacy, Engineering, Life Sciences, Pharmaceutical Sciences or a related scientific discipline.
• Prior experience in Regulatory Affairs within the pharmaceutical industry, with knowledge of product registration processes and regulatory documentation.
• Strong attention to detail, organizational and analytical abilities, and the capacity to manage multiple priorities under defined timelines.
• Proficiency in English and French (written and spoken) and good command of Microsoft Office tools.