Regulatory Affairs Lead (Healthcare & Pharma)

Legal & Compliance

K sh 200,000 – 350,000 gross / month

Openings: 1 Location: Nairobi – Ridgeways (Kiambu Rd, Ridgeways Mall vicinity) Overview: Our client is on the hunt for a sharp Regulatory Affairs Lead to steer product registrations, variations, and post-market vigilance for a healthcare distributor handling devices, OTC, and select Rx products. You’ll be the bridge between science, law, and commercial teams, translating complex regulations into compliant labels, claims, and promotional guardrails that the business can actually use. Day-to-day, you’ll manage dossiers, renewals, and submissions with PPB, KEBS, and occasionally NEMA, keeping approvals timely and inspection-ready. If spotting regulatory gaps before they become headaches is your jam, this role puts you in the driver’s seat. You’ll also coach Sales and Marketing on compliant practices, train teams on SOPs, and coordinate audits or product recalls. Think of yourself as the compliance compass, ensuring every claim, label, and submission aligns with the law, while keeping the company agile. In short, this role blends technical rigor with practical, business-facing solutions, giving you both visibility and influence over regulatory strategy. Key Responsibilities: - Prepare dossiers; manage submissions/variations/renewals with PPB/KEBS. - Review labels, IFUs, and marketing claims for compliance. - Maintain vigilance system; investigate and report field safety issues. - Map regulatory changes; brief leadership; update SOPs. - Train Sales/Marketing on do’s & don’ts (samples, sponsorships, CME). - Coordinate audits and product recalls (mock and real). Education & Experience: - Pharmacy/Biomedical/LL.B + RA experience; 4–6 years in RA/QA/medical affairs. Skills & Tools: - Dossier prep, GMP/ISO 13485 basics, document control, stakeholder comms. KPIs: - Approval lead time, renewal timeliness, inspection outcomes, and recall readiness. Compensation (Kenya): KES 200,000–350,000 + annual bonus. Figures are estimates shared by our clients and vary with your experience, interview performance, certifications, and company pay bands. Benefits: - Medical, pension, CPD, professional fees. Growth Path: - Senior RA Lead → Head of Regulatory & Quality → Medical/RA Director. Ideal hierarchy and expected promotion cycle.