Supervisor, Regulatory Affairs

Location:
Algiers, Algeria

Job Type
Full-time

About Us
For over 45 years, Hikma Pharmaceuticals has been putting better health within reach, every day, by creating high-quality medicines and making them accessible to those who need them. We are helping to shape a healthier world that enriches all our communities, and our global team of 9,500+ empowered employees are central to this mission. As a trusted and reliable partner of over 800 high-quality generics, specialty and branded pharmaceutical products, we are driven to improve access to medicine. Through our 29 manufacturing plants, 9 R&D centers across the MENA, North America and Europe, our footprint allows us to play a critical role in serving patients. Description: We are looking for a talented Supervisor, Regulatory Affairs to join us. At Hikma you’ll be supported by a culture of progress and belonging where people are encouraged to develop, wellbeing is prioritised and our inclusive approach values contributions from all. We’re seeking candidates who embody our values: Innovative, driven to keep learning; Caring, genuinely compassionate in their work; and Collaborative, eager to solve problems together. If you want to be part of a team that cares about impact, this is the place for you. Main

Responsibilities:
• Supervise the preparation, review, and submission of regulatory dossiers, including new registrations, renewals, variations, transfers, and line extensions.
• Ensure that regulatory dossiers comply with Algerian regulatory requirements and internal procedures.
• Monitor regulatory deadlines and ensure the continued compliance of products 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 in carrying out their responsibilities.
• Monitor regulatory developments and assess the impact of regulatory changes on the company’s activities.
• Collaborate with various internal departments to ensure the regulatory compliance of products and their associated materials.
• Participate in regulatory audits and inspections and ensure compliance with internal procedures. Required

Skills:
• Strong attention to detail, organizational skills, and analytical thinking.
• Excellent communication and coordination skills.
• Leadership skills and the ability to manage multiple projects simultaneously.
• Results-oriented mindset and strong problem-solving skills in regulatory matters. Academic Background and Knowledge:
• Doctor of Pharmacy or State Diploma in Pharmacy, with registration with the Order of Pharmacists.
• Minimum of 5 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Strong knowledge of Algerian pharmaceutical regulations and registration procedures.
• Experience in managing CTD/eCTD dossiers, renewals, and variations.
• Experience in team supervision or project coordination is an asset. Learn more about Hikma in Algeria hikma-algeria-factsheet-aug-2025-en.pdf