Head of Regulatory Affairs

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 i