Regulatory Affairs Specialist

Atome Pharma Group; Dubai; On-site; AED 300,000 - 600,000; Full time

Job summary

Atome Pharma Group is seeking a senior regulatory affairs professional to lead submissions across Africa and MENA, coordinating CTD/eCTD dossiers and liaising with manufacturers, authorities and consultants.

The role emphasizes staying abreast of regulatory changes, managing multiple countries and timelines, and supporting market expansion with rigorous regulatory governance.

Qualifications

• 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.

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 new 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.

Skills

Regulatory affairs experience

CTD/eCTD dossiers

Regulatory submissions

English fluent

French desirable

Attention to detail

Project management

Multi-country coordination

Job description

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 new 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.

• 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.