Head of Regulatory Affairs & Pharmacovigilance

Klea Pharmaceuticals LLC; Dubai; On-site; AED 400,000 - 800,000; Full time

Benefits offered by this job

Medical insurance

Annual leave

Air ticket

Visa sponsorship and licensing support

Job summary

Klea Pharmaceuticals LLC, a Dubai-based subsidiary of Klea Holding, is building its UAE/MEA regulatory, safety and scientific-officer framework. The Head of Regulatory Affairs & Pharmacovigilance will own MOHAP registrations, PV system development, and the Pharmacist in Charge licence, while guiding MAH transfers and lifecycle management.

The role requires a hands-on builder with the ability to design SOPs, manage inspections, and coordinate cross-functional regulatory activities across devices,

Qualifications

• Postgraduate qualification in regulatory affairs, pharmaceutical medicine, pharmacovigilance or quality.
• Formal PV certification (e.g. QPPV training, ISoP or equivalent).
• Existing MOHAP, DoH or DHA licensing in a comparable named-role capacity.

Responsibilities

• Own MOHAP registration pathway and lifecycle for new products.
• Lead MAH transfers and portfolio continuity planning.
• Manage variations, pricing submissions and import permits.
• Build and maintain PV system, PSMF and training programmes.
• Act as Qualified Person for Pharmacovigilance for UAE.
• Prepare safety reports, risk management plans and signal detection.
• Negotiate PVAs and ensure partner compliance.
• Prepare organisation for PV inspections and CAPA closure.
• Provide regulatory input to tender submissions and BD activities.
• Serve as Pharmacist in Charge on MOHAP licence and ensure licence scope.

Skills

Independence of judgement

Regulatory authority

SOPs & trackers

Commercial literacy

High‑volume execution

One-person function

Education

Postgraduate qualification in regulatory affairs

Formal PV certification

MOHAP/DoH/DHA licensing in similar role

Job description

Klea Pharmaceuticals LLC, a Dubai-based subsidiary of Klea Holding, is building its UAE/MEA regulatory, safety and scientific-officer framework. The Head of Regulatory Affairs & Pharmacovigilance will own MOHAP registrations, PV system development, and the Pharmacist in Charge licence, while guiding MAH transfers and lifecycle management.

The role requires a hands-on builder with the ability to design SOPs, manage inspections, and coordinate cross-functional regulatory activities across devices,