UAE PV & Regulatory Affairs Specialist

New Country Healthcare; Dubai; On-site; AED 300,000 - 420,000; Full time

Job summary

New Country Healthcare is seeking an Pharmacovigilance & Regulatory Affairs Officer to ensure UAE regulatory and PV compliance across the product life cycle. You will serve as the local PV focal point and coordinate safety reporting, regulatory submissions, and compliance activities with Emirates Drug Establishment, Dubai Municipality, and internal stakeholders.

You will drive PV governance, safety data handling, and regulatory intelligence, supporting audits, batch release, medical information,

Qualifications

• Bachelor’s degree in Pharmacy or Life Sciences with UAE regulatory exposure.
• 4–7 years of progression in Pharmacovigilance and Regulatory Affairs in UAE healthcare.
• Experience coordinating with Emirates Drug Establishment and Dubai Municipality.

Responsibilities

• Obtain and maintain the Pharmacovigilance licence from Emirates Drug Establishment as local PV focal point.
• Coordinate PV processes, safety reporting, and regulatory submissions with regulators and principals.
• Prepare PV SOPs, templates, and working instructions to reflect regulatory updates.
• Lead PV training, audit readiness, and CAPA management with cross‑functional teams.
• Review labels, leaflets, and registration dossiers for UAE compliance and safety alignment.

Skills

PV governance

Regulatory affairs

SDEA agreements

Audit readiness

CAPA management

Documentation control

Stakeholder management

Safety reporting

Education

Bachelor’s degree in Pharmacy

Bachelor’s degree in Life Sciences

Job description

New Country Healthcare is seeking an Pharmacovigilance & Regulatory Affairs Officer to ensure UAE regulatory and PV compliance across the product life cycle. You will serve as the local PV focal point and coordinate safety reporting, regulatory submissions, and compliance activities with Emirates Drug Establishment, Dubai Municipality, and internal stakeholders.

You will drive PV governance, safety data handling, and regulatory intelligence, supporting audits, batch release, medical information,