Head of Regulatory Affairs & Pharmacovigilance Pharmacist in Charge — Scientific Office

Klea Pharma; 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, a Dubai-based subsidiary of Klea Holding (Euronext Growth Paris), is building its UAE and wider MEA presence through in-licensed and acquired portfolios spanning prescription medicines, medical devices and nutraceuticals. This role is the single accountable owner of the company's regulatory, safety and scientific-office compliance framework.

The postholder wears three hats:

Head of Regulatory Affairs — securing and maintaining market authorisations, pricing approvals and import clearances across the UAE and priority MEA markets.

Qualified Person for Pharmacovigilance (QPPV) — establishing and running a compliant, inspection-ready PV system.

Pharmacist in Charge — the MOHAP-licensed responsible pharmacist named on Klea's scientific office licence, personally accountable for the lawful conduct of all scientific and promotional activity.

This is a build role, not a maintenance role. The successful candidate will stand up systems, SOPs and regulatory files largely from a blank sheet, while simultaneously executing a live portfolio transfer and launch pipeline.

2. Key responsibilities

A. Regulatory affairs — registration and lifecycle

• Own the end-to-end MOHAP registration pathway for new products: company registration, product dossier compilation and submission, sample and analysis coordination, query response, and approval follow-through.
• Lead Marketing Authorisation Holder (MAH) transfers for acquired portfolios, including dossier gap analysis, transfer applications, artwork transition and continuity-of-supply planning to minimise commercial disruption during changeover.
• Manage variations, renewals and lifecycle maintenance across the registered portfolio; maintain a master registration tracker with status, expiry and action dates visible to the leadership team.
• Prepare and defend pricing submissions to the MOHAP pricing committee, including reference-country pricing files, and manage repricing exercises and price-erosion risk in coordination with the commercial team.
• Secure and maintain import permits, release documentation and shipment clearances in coordination with the distribution partner and customs brokers.
• Handle medical device registration (including Class IIb/III devices such as viscosupplements) and food supplement / nutraceutical registration through the relevant MOHAP, ESMA, Dubai Municipality and ADAFSA channels, advising the business on the correct classification pathway before commitments are made.
• Manage Tatmeen serialisation and track-and-trace onboarding and ongoing compliance for all applicable products.
• Review and secure approval for all packaging artwork, labelling, patient information leaflets and Arabic translations.
• Review, approve and archive all promotional and scientific material prior to use; act as final signatory for regulatory compliance of promotional claims.
• Build the regulatory intelligence function: track MOHAP, DoH and DHA circulars, guidance updates and GCC harmonisation developments, and brief the leadership team on commercial implications.
• Provide regulatory input into business development: dossier due diligence, registration feasibility and timeline estimates, and regulatory risk assessment for in-licensing and acquisition candidates.
• Act as the named Qualified Person for Pharmacovigilance for Klea in the UAE, with 24/7 contactability as required by MOHAP.
• Design, implement and maintain the company's PV system, including the PV System Master File (PSMF), SOP suite, safety database or equivalent record system, and training programme.
• Manage adverse event and product-quality-complaint intake, triage, causality assessment, documentation and onward reporting to MOHAP within mandated timelines.
• Prepare and submit periodic safety reports (PSUR/PBRER), Risk Management Plans and any local addenda required by the authority.
• Conduct signal detection and literature screening appropriate to the portfolio; elevate and act on emerging safety findings.
• Negotiate, execute and maintain Pharmacovigilance Agreements (PVAs) / Safety Data Exchange Agreements with principals, licensors, distributors and CROs; monitor partner compliance.
• Own recall, field safety corrective action and product withdrawal readiness — including the written recall procedure, mock‑recall testing and authority notification.
• Prepare the organisation for PV inspection and audit; manage CAPA to closure.
• Deliver annual PV and adverse-event awareness training to all commercial, medical and supply‑chain staff.

C. Pharmacist in Charge — Scientific Office

• Serve as the MOHAP‑licensed Pharmacist in Charge named on Klea's scientific office licence, and maintain that licence in good standing.
• Ensure all scientific office activity remains within the permitted scope of the licence — scientific and promotional support without prohibited trading activity — and advise the business clearly where a proposed activity falls outside scope.
• Maintain the licence lifecycle: renewals, amendments, facility inspections, staff licensing and any changes to the licensed premises or activity.
• Ensure medical representative activity, sample handling and scientific engagement comply with MOHAP promotional and ethical‑conduct requirements.
• Own the document control, record retention and archiving system required for authority inspection.
• Act as primary point of contact and relationship owner with MOHAP, DoH Abu Dhabi and DHA.

D. Cross-functional and commercial partnering

• Sit in commercial planning as the regulatory voice: provide realistic registration and launch timelines that the business can plan against, and flag risk early rather than late.
• Support the distribution partner with regulatory documentation, training and compliance alignment.
• Contribute regulatory and safety input to tender submissions, listing applications and institutional business.
• Support supplier and manufacturer qualification, including GMP documentation review and technical agreement input.

3. Qualifications and licensing

• Sit in commercial planning as the regulatory voice: provide realistic registration and launch timelines that the business can plan against, and flag risk early rather than late.
• Support the distribution partner with regulatory documentation, training and compliance alignment.
• Contribute regulatory and safety input to tender submissions, listing applications and institutional business.
• Support supplier and manufacturer qualification, including GMP documentation review and technical agreement input.
• 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.

4. Experience

• Minimum 8 years in pharmaceutical regulatory affairs, of which at least 4 years in the UAE dealing directly with MOHAP.
• Demonstrated personal ownership of successful MOHAP product registrations from submission through approval — candidates should be able to speak to specific files they have carried.
• Practical experience of MAH transfer or portfolio acquisition regulatory workstreams is a strong advantage and directly relevant to Klea's near‑term agenda.
• Hands‑on pharmacovigilance experience, ideally as a named QPPV or deputy, including at least one authority inspection or audit.
• Experience across more than one product class — medicines plus devices and/or supplements — given the breadth of Klea's portfolio.
• Experience in a small or start‑up affiliate, where the postholder built rather than inherited systems, is preferred over large‑multinational experience in a narrow specialist lane.
• Exposure to wider MEA or GCC registration, and to Francophone Africa, is an advantage.

5. Skills and attributes

• Genuine independence of judgement. This role carries personal regulatory accountability. The postholder must be willing to say no to the commercial organisation, in writing, and hold that position.
• Strong authority relationships and the credibility to resolve issues through dialogue rather than escalation.
• Systems builder — comfortable writing SOPs, designing trackers and creating structure where none exists.
• Commercially literate: able to frame regulatory constraints in terms of launch dates, cost and risk rather than pure compliance language.
• High‑volume execution capability with meticulous documentation discipline.
• Comfortable operating as a one‑person function initially, with the ambition and capability to build and lead a team.

6. First 12 months — what success looks like

• Scientific office licence secured or transferred and in good standing, with the postholder named as Pharmacist in Charge.
• Complete portfolio registration status mapped, with a prioritised submission and renewal calendar agreed with the leadership team.
• MAH transfer workstream for the acquired portfolio executed with no avoidable supply interruption.
• PV system operational and inspection‑ready: PSMF in place, SOPs approved, intake and reporting process live, all staff trained, PVAs executed with all active partners.
• Pricing approvals obtained for the launch portfolio at levels consistent with the commercial plan.
• Tatmeen compliance achieved across all applicable SKUs.
• Regulatory function established as a reliable input to commercial planning — timelines given are timelines met.

7. Package

Competitive base salary commensurate with experience, plus performance bonus, medical insurance, annual leave and air ticket in line with UAE Labour Law and Klea policy. Visa and licensing support provided. Specific package to be discussed at offer stage.

Head of Regulatory Affairs & Pharmacovigilance

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Klea Pharmaceuticals is an equal opportunity employer.