Regulatory Affairs Officer

Job Summary:

We are seeking a detail-oriented Regulatory Affairs Officer with 3–4 years of experience in the pharmaceutical industry. The candidate will be responsible for ensuring compliance with local regulatory requirements, supporting product registrations, and maintaining regulatory documentation in line with UAE health authority guidelines. B-Pharm/M-Pharma candidate with PV and Pharmacist license is preferred.

Key Responsibilities:

• Prepare and submit regulatory dossiers for product registration, renewal, and variations in the UAE.
• Ensure compliance with local regulations, guidelines, and applicable international standards.
• Respond to regulatory queries as needed.
• Maintain regulatory databases and ensure timely updates of product licenses.
• Review artworks to ensure regulatory compliance.
• Liaise with internal departments (Supply Chain, Marketing) and external partners.
• Track submission timelines and follow up on approvals.
• Pharmacovigilance and post-marketing regulatory activities as required.
• Stay updated with changes in regulatory requirements and communicate impacts internally.

Qualifications & Requirements:

• Bachelor’s / master’s degree in pharmacy, (B-Pharm/M-Pharma; Candidate with PV and Pharmacist license preferred)
• 3–4 years of experience in Regulatory Affairs within UAE.
• Good knowledge of UAE regulatory authorities’ submission processes.
• Familiarity with CTD/eCTD dossier formats.
• Strong documentation, communication, and organizational skills.
• Proficiency in MS Office applications.

Key Competencies:

• Regulatory compliance awareness

· Time management

· Team collaboration

Work Location: In person