Requirements
The candidate must have 2-5 years of experience in Regulatory Affairs, Quality Assurance, or pharmaceutical documentation, with a preference for experience in pharmaceuticals and/or medical devices. Practical exposure to Africa and/or MENA regulatory requirements is highly preferred. A basic understanding of CTD/eCTD, product registration, renewals, variations, and GMP is required, along with strong document management skills, proficiency in MS Office/Excel, and fluent English. French fluency is an advantage.
Description
Job description / Role
Job Type
Full Time
Job Location
Dubai, UAE
Nationality
Any Nationality
Salary
Not Specified
Gender
Not Specified
Arabic Fluency
Not Specified
Job Function
Healthcare
Company Industry
General Trading & Import/Export
KEY RESPONSIBILITIES
Regulatory Affairs
• Support preparation, compilation and review of CTD/eCTD and country-specific registration dossiers.
• Collect and coordinate regulatory documents from manufacturers, including GMP, CPP, FSC, manufacturing licences, DMF/CEP, CoA, specifications and stability data.
• Support new product registrations, renewals, variations and regulatory submissions.
• Maintain regulatory trackers for submissions, approvals, renewals and variations.
• Follow up on regulatory authority queries, deficiency letters and pending documents.
• Coordinate with local agents, consultants and regulatory authorities when required.
• Monitor registration timelines and ensure timely submission of documents.
• Support regulatory research for new African and MENA markets.
Quality Assurance
• Maintain and organize product quality and compliance documentation.
• Review documents for completeness, consistency and compliance with requirements.
• Support collection and review of CoAs, specifications, GMP certificates, licences, stability data and other quality documents.
• Coordinate with manufacturers on quality documentation and outstanding requirements.
• Support QA documentation, supplier/manufacturer qualification and audit-related activities.
• Maintain controlled records, trackers and QA/RA databases.
• Support preparation and follow-up of quality complaints, deviations, CAPA and other QA activities, as applicable.
Coordination & Administration
• Maintain accurate electronic and physical QA/RA records.
• Prepare document checklists and follow up with manufacturers and internal teams.
• Coordinate with Business Development, Procurement, Supply Chain and Finance teams.
• Ensure all regulatory and quality documents are properly filed and readily available.
• Support multiple products, countries and deadlines simultaneously.
Requirements:
• 2–5 years of experience in Regulatory Affairs, Quality Assurance or pharmaceutical documentation.
• Experience in pharmaceuticals and/or medical devices preferred.
• Practical exposure to Africa and/or MENA regulatory requirements is highly preferred.
• Basic understanding of CTD/eCTD, product registration, renewals and variations.
• Good understanding of GMP and pharmaceutical quality documentation.
• Strong document management and attention to detail.
• Good follow-up, coordination and communication skills.
• Proficient in MS Office/Excel and document management systems.
• Fluent English required; French is an advantage.
• Ability to work independently and manage multiple priorities.
About the Company
Atome Pharma Group is presently one of the leading pharmaceutical service providers in both private and public sector, in emerging countries with a focus in African countries with limited access to quality health.
Our presence in the UAE and throughout Africa allows us to have an excellent control of covered areas with the support of senior executives who have lived there, as well as stable teams, both on the ground and in our headquarters These elements give Atome Pharma a great knowledge of the specificities of each territory.
From Dubai to Dakar through Abidjan, Yaoundé, and other capitals, women and men at Atome Pharma Group carry on our work passionately, which gives us a constant reactivity and a sense of professionalism at Service of partners as demanding as faithful.
We are proud to have a team representing 5 different nationalities across our five locations Diversity is at the core of our strength enabling us to fulfil our purpose with greater impact.
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