ABOUT THE ROLE

ATOME PHARMA GROUP is looking for an experienced Regulatory Affairs Specialist with practical experience in Africa and MENA markets to manage pharmaceutical and medical device registrations and regulatory activities across the region.

The role will involve regulatory strategy, dossier preparation and review, submissions, registrations, renewals and variations, while coordinating closely with manufacturers, regulatory authorities, local agents and internal teams.

KEY RESPONSIBILITIES

- Develop regulatory strategies and manage product registrations, renewals and variations across Africa and MENA.
- Prepare, review and coordinate CTD/eCTD and country-specific regulatory dossiers.
- Coordinate with manufacturers to obtain and review required documents, including GMP, CPP, FSC, DMF/CEP, CoA, specifications, stability data and manufacturing licences.
- Manage regulatory submissions, authority queries, deficiency letters and responses through to approval.
- Maintain an updated regulatory tracker covering submissions, approvals, renewals, variations and regulatory commitments.
- Liaise with National Regulatory Authorities, local agents and regulatory consultants.
- Support product selection and recent market expansion by providing regulatory feasibility and requirements.
- Monitor regulatory changes in Africa and MENA and advise relevant internal teams.
- Work closely with QA, Business Development, Procurement and manufacturers to ensure timely and compliant submissions.
- Ensure regulatory documentation is properly maintained and activities are completed within agreed timelines.

CANDIDATE PROFILE





- 5-10+ years of Regulatory Affairs experience in pharmaceuticals and/or medical devices.
- Proven hands-on experience with Africa and MENA regulatory submissions and registrations.
- Good knowledge of Francophone and/or Anglophone African markets.
- Strong experience in CTD/eCTD dossiers, renewals, variations and regulatory queries.
- Good understanding of GMP and pharmaceutical regulatory documentation.
- Experience coordinating with manufacturers, regulatory authorities, agents and consultants.
- Strong attention to detail, organisational and project-management skills.
- Ability to manage multiple countries, products and deadlines independently.
- Fluent English required; French is highly desirable.
- Willingness to travel internationally when required.

PREFERRED EXPERIENCE Experience in markets such as Ivory Coast, Senegal, Cameroon, Burkina Faso, Mali, Guinea, Benin, Rwanda, Kenya, Nigeria, Ghana and GCC/MENA countries will be an advantage.

Experience with GCC and other international regulatory requirements will be highly valued.

IDEAL CANDIDATE A hands-on and proactive Regulatory Affairs professional who understands the practical regulatory requirements of Africa and MENA and can independently manage the process from regulatory assessment and dossier preparation through submission, authority queries and final approval.

The candidate should be commercially aware and comfortable working across multiple countries with manufacturers, regulatory authorities, local agents and internal teams.

Interested candidates send CV to [email protected] and [email protected]

📌 Regulatory Affairs Specialist (Mumbai)
🏢 Atome Pharma Group
📍 Mumbai