ABOUT THE ROLE

We are looking for a detail-oriented and proactive QA & RA Assistant to support quality assurance and regulatory activities for pharmaceutical and medical device products across Africa and MENA.

The role will involve documentation, dossier preparation, regulatory submissions, manufacturer follow-up, product registration support, and maintaining QA/RA records and trackers.

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.

CANDIDATE PROFILE

- 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.
- Valuable 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.

PREFERRED MARKET EXPERIENCE Experience with regulatory activities in Francophone/Anglophone Africa and GCC/MENA, particularly countries such as Ivory Coast, Senegal, Cameroon, Burkina Faso, Mali, Guinea, Benin, Rwanda, Kenya, Nigeria, Ghana and GCC markets.

IDEAL CANDIDATE A hands-on, organized and detail-oriented QA/RA professional who can effectively coordinate with manufacturers, regulatory teams and internal departments, follow up on pending documentation, and support product registrations across multiple African and MENA markets.

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

📌 QA & RA Assistant (Mumbai)
🏢 Atome Pharma Group LLC FZ
📍 Mumbai