Job Details

Job Purpose

To secure, maintain, and defend the product registrations, licences, and safety compliance that allow us to import, market, and distribute our portfolio of OTC and nutrition products, prescription medicines, medical devices, and, progressively, pet-care products across Kenya and East Africa. The immediate priority is regulatory affairs — accelerating new product registrations, variations, and renewals in support of the commercial launch plan — with the role also establishing a fit-for-purpose pharmacovigilance system and supporting quality assurance across the supply chain.

Key Responsibilities

1. Product Registration & Regulatory Strategy (Primary Focus)

• Own end-to-end registration of new products — OTC, food supplements, prescription medicines, medical devices, and pet-care products where applicable — with PPB, KEBS, and the VMD in Kenya, and with TMDA, Uganda’s NDA, and Rwanda FDA regionally, directly or through appointed agents.

• Build and maintain a prioritised registration pipeline aligned to commercial launch plans, with realistic timelines and early flagging of risks and delays.

• Compile and submit high-quality registration dossiers, coordinate regulator query responses, and follow every application through to approval.

• Advise on regulatory classification and route-to-market before commercial commitments are made, and support due diligence on new principals and portfolios.

2. Licences, Compliance & Lifecycle Maintenance

• Maintain all company and product licences, permits, and import authorisations, ensuring renewals complete well before expiry.

• Manage variations, renewals, and label changes, and ensure packaging and claims remain compliant with approved registrations.

• Review promotional and training materials for compliant, approved claims, and support import/consignment compliance documentation.

• Maintain complete, audit-ready regulatory files and correspondence records.

3. Pharmacovigilance & Product Safety

• Establish and operate the pharmacovigilance system — SOPs, adverse-event intake, assessment, and reporting within required timelines.

• Manage individual case safety reports and periodic safety reporting obligations.

• Train commercial and sales teams on adverse-event and complaint reporting obligations, and coordinate recalls and corrective actions with supply chain and principals.

4. Quality Assurance Support

• Support good distribution and storage practices — storage conditions, batch traceability, expiry management.

• Develop and maintain SOPs, and support deviation management, CAPA, and change control.

• Manage product quality complaints and coordinate investigations with principals and internal teams.

5. Regulatory Intelligence & Authority Relations

• Build and maintain working relationships with PPB, KEBS, VMD, and regional regulators and agents.

• Monitor and interpret regulatory changes and EAC harmonisation initiatives, advising the business on required action.

6. Cross-Functional Support & Reporting

• Partner with commercial, marketing, and supply chain teams so launch plans stay aligned with regulatory approvals.

• Prepare a monthly report covering the registration pipeline, compliance status, pharmacovigilance activity, and key risks.

Key Performance Indicators

Performance Area	Indicative Measures
Registration delivery	New product registrations approved versus plan; dossier submission timeliness; regulator query-response turnaround; registration pipeline accuracy.
Licence compliance	Percentage of marketed products with valid registrations and licences; renewals completed before expiry; zero distribution of unregistered products.
Pharmacovigilance	Adverse events reported within required timelines; PV SOPs implemented; staff trained; principal safety obligations met.
Quality assurance	SOP coverage and adherence; CAPA closure rates; audit findings closed on time; quality-complaint handling turnaround.
Regulatory intelligence	Timeliness and quality of regulatory impact assessments; screening support for new products and partners; EAC registration coordination quality.
Reporting & documentation	Completeness and audit-readiness of regulatory files; accuracy of trackers; quality and timeliness of monthly reporting.

Qualifications and Experience

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Biomedical Sciences, or a related field; registration as a pharmacist with the Pharmacy and Poisons Board is an advantage.

• At least 4 years’ regulatory affairs experience in Kenya or East Africa, covering OTC and nutrition/food-supplement products, prescription medicines, and medical devices; experience with veterinary or pet-care products is a strong advantage.

• Proven track record of successful product registrations with PPB, and working knowledge of KEBS requirements.

• Experience managing product registrations in at least one other EAC market — TMDA (Tanzania), NDA (Uganda), or Rwanda FDA — directly or through local agents; experience across all three markets and familiarity with the EAC Medicines Regulatory Harmonisation initiative are strong advantages.

• Hands-on pharmacovigilance experience, including adverse-event handling, safety reporting, and the development or operation of a pharmacovigilance system.

• Quality assurance experience (GMP/GDP principles, SOP development, audits, CAPA) is strongly preferred.

• Strong dossier-preparation and technical-writing skills, exceptional attention to detail, and working knowledge of Microsoft Office and regulatory tracking tools.

Core Competencies

Technical and Regulatory • Regulatory dossier preparation and submission • Product classification and claims assessment • Pharmacovigilance systems and safety reporting • Quality systems (GDP/GMP, SOPs, CAPA) • Regulatory intelligence and interpretation • Project and pipeline management

Behavioural • Rigour and attention to detail • Integrity and ethical judgement • Organisation and follow-through • Communication and stakeholder management • Pragmatic problem-solving • Autonomy in a fast-paced environment

Key Working Relationships

Internal • Head of Medical & Regulatory • Chief Executive Officer / General Manager and leadership team • Sales and Commercial teams • Marketing Brand Manager • Supply Chain and Warehouse

External • Pharmacy and Poisons Board (PPB) • KEBS, VMD, and regional regulators (TMDA, Uganda NDA, Rwanda FDA) • Principals and manufacturers • Regulatory consultants and clearing agents • Industry associations and technical bodies

How to Apply

Interested and qualified candidates should send their CV and a cover letter to:

Email: hiring@kizunaedgetalenthub.com by 7^th September 2026

Subject line: Regulatory Affairs & Pharmacovigilance Manager