Quality Assurance & Regulatory Affairs Assistant

Atome Pharma Group; Dubai; On-site; AED 180,000 - 360,000; Full time

Job summary

Atome Pharma Group is seeking a Regulatory Affairs/QA specialist in Dubai to support CTD/eCTD dossier preparation, coordinate with manufacturers and authorities, and assist with registrations, renewals and variations.

You will maintain regulatory trackers, respond to queries, and collaborate with local agents and internal teams to ensure timely submissions while supporting regulatory research for Africa and MENA markets.

Qualifications

• 2–5 years of experience in regulatory affairs or QA in pharma.
• Experience with CTD/eCTD and product registrations preferred.
• Experience in Africa/MENA regulatory requirements preferred.
• Fluent English; French is a plus.
• Strong document management and attention to detail.
• Ability to manage multiple priorities and coordinate with teams.

Responsibilities

• Support preparation and review of CTD/eCTD dossiers.
• Coordinate regulatory documents with manufacturers and authorities.
• Support registrations, renewals, variations, and submissions.
• Maintain regulatory trackers and respond to authority queries.
• Coordinate with local agents and QA/RA teams.
• Monitor timelines and ensure timely submission.
• Support regulatory research for Africa and MENA markets.

Skills

Regulatory affairs

Quality assurance

Documentation management

Coordination

Communication

Tools

MS Office

Excel

Document management systems

Job description

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.