Supervisor, Regulatory Affairs

About the role

Hikma Pharmaceuticals, a generic, specialty and branded pharma group active for over 45 years, is looking for a Supervisor, Regulatory Affairs to join its team in Algiers. The role supervises the preparation, review and submission of regulatory dossiers and supports Regulatory Affairs Officers.

Key responsibilities

• Supervise the preparation, review and submission of regulatory dossiers, including new registrations, renewals, variations, transfers and line extensions.
• Ensure dossiers comply with Algerian regulatory requirements and internal procedures.
• Monitor regulatory deadlines and keep products compliant throughout their lifecycle.
• Coordinate interactions with health authorities and follow up on requests for additional information and technical observations.
• Supervise, guide and support Regulatory Affairs Officers.
• Monitor regulatory developments and assess the impact of regulatory changes on the company's activities.
• Collaborate with internal departments to ensure regulatory compliance of products and their materials.
• Take part in regulatory audits and inspections and ensure compliance with internal procedures.

Required profile

• Doctor of Pharmacy or State Diploma in Pharmacy, registered with the Order of Pharmacists.
• At least 5 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Strong knowledge of Algerian pharmaceutical regulations and registration procedures.
• Experience managing CTD/eCTD dossiers, renewals and variations.
• Team supervision or project coordination experience is an asset.

Required skills

• Attention to detail, organization and analytical thinking.
• Excellent communication and coordination skills.
• Leadership skills and ability to manage several projects at once.
• Problem-solving skills in regulatory matters.