Regulatory Affairs Associate

The Regulatory Affairs Associate to play a key role in managing and executing affiliate-level regulatory affairs operations to support product lifecycle management and market access. This position is responsible for ensuring regulatory compliance throughout product registration, license maintenance, labelling updates, and post-approval activities, while aligning with local UAE regulations, Ministry of Health (MOH)/EDE requirements, and global quality systems. The role also supports operational excellence by maintaining accurate regulatory records and fostering effective relationships with regulatory authorities.

• Lead all regulatory submissions, registrations, renewals, and variations for UAE and other GCC regions including KSA.
• Ensure compliance with EDE, ESMA, municipalities, SFDA, and other relevant authorities.
• Prepare, review, and manage regulatory documentation, technical files, and product dossiers as and when applicable.
• Review and approve product labels, artworks, claims, and marketing materials.
• Work closely with international suppliers to gather and validate regulatory documents.
• Maintain regulatory trackers, databases, and audit-ready records.
• Support product launches across pharmacy, retail, modern trade, and e-commerce channels.
• Provide regulatory advice to leadership and internal teams on compliance and market requirements.
• Ensure imported products meet all UAE and GCC regulatory standards.

A successful Regulatory Affairs Associate should have:

• Bachelor’s degree in pharmacy (mandatory).
• 4-5 years of Regulatory Affairs experience within UAE/GCC.
• Strong knowledge in Pharma, Medical Devices, and GSL category UAE/GCC regulatory guidelines.
• Ability to adapt effectively to complex regulatory challenges and evolving requirements.
• Proven experience with EDE, SFDA, ESMA, and municipality submissions.
• Fluency in English (both spoken and written) is required. Arabic is preferrable.
• Highly hands-on, proactive, and detail oriented.
• Excellent time management and organizational capabilities.
• Proven ability to build and maintain positive working relationships with internal stakeholders and external regulatory authorities.

Job Type: Full-time

Pay: From AED15,000.00 per month

Education:

• Bachelor's (Preferred)

Experience:

• EDE, SFDA, ESMA, and municipality submissions: 4 years (Preferred)
• Pharma, Medical Devices, and GSL category: 4 years (Preferred)

Language:

• English (Preferred)
• Arabic (Preferred)

License/Certification:

• UAE Pharmacist License (Required)