QA & Regulatory Affairs Specialist (Africa/MENA)

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

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.