Regulatory Affairs & Training Manager

Regulatory Affairs & Training Manager

Direct Line Reporting: Managing Director / Country Manager

Industry Sector: Medical / Pharmaceutical Distribution

Gross Salary Structure: Open / Competitive

Location: Nairobi, Kenya

Role Overview

We are seeking an experienced, executive-ready Regulatory Affairs & Training Manager to spearhead our regulatory compliance strategy and internal capability development frameworks. Your primary objective is twofold: navigate complex pharmaceutical product registration pipelines, renewals, and variations in accordance with Pharmacy and Poisons Board (PPB) guidelines, while designing high-impact training modules for commercial and technical staff. This position bridges rigorous statutory governance with organizational learning; you will manage every variable from direct regulatory authority liaison and compliance audits through to technical onboarding and product knowledge coaching. The role demands an authoritative, strategic leader holding a Pharmacy or Life Sciences background, proven stakeholder diplomacy, and deep operational familiarity with Kenyan healthcare regulations.

Core Competencies

Regulatory Governance & Product Registrations

• Lead end-to-end product registration workflows, renewals, site dossiers, and technical variation submissions to secure timely market authorizations.
• Align all imported and distributed pharmaceutical portfolios with current Kenyan healthcare legislation, safety mandates, and import-export protocols.
• Serve as the primary corporate liaison to regulatory agencies, managing official communications, inspections, and licensing frameworks professionally.
• Monitor updates to local and regional pharmaceutical legislation, delivering actionable compliance advisories to senior leadership.
• Prepare comprehensive technical dossiers, batch release records, and submission packages to streamline authorization timelines.
• Direct internal compliance audits and host external regulatory inspections, instituting fast corrective and preventive actions (CAPA) where needed.

Workforce Training & Capability Building

• Formulate and deploy structured learning frameworks and technical curriculum for commercial representatives, supply chain officers, and technical personnel.
• Conduct diagnostic training needs analyses across departments to pinpoint knowledge gaps and build targeted coaching modules.
• Deliver interactive technical sessions covering regulatory guidelines, pharmacovigilance reporting, product profiles, and ethical marketing codes.
• Measure post-training performance metrics and continuous improvement loops to evaluate knowledge retention and field execution.
• Direct new employee onboarding programs and facilitate ongoing professional development tracks across operational divisions.

Cross-Functional Strategy & Risk Oversight

• Partner closely with Quality Assurance, Logistics, Commercial Sales, and international principals to align product launches with clearance dates.
• Evaluate regulatory risks associated with portfolio expansion, advising executive teams on market entry feasibility and statutory barriers.
• Maintain an indexed digital archive of all registration certificates, import permits, product dossiers, and official correspondence.

Skills & Experience Required

Minimum Entry Criteria

• Academic Foundation: Bachelor’s Degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a closely related medical discipline from a recognized university.
• Industry Experience: Minimum of 7 years of progressive experience in regulatory affairs within the pharmaceutical or healthcare distribution sectors in Kenya.
• Track Record: Demonstrated success managing product submissions, regulatory renewals, and formal engagements with statutory bodies like the Pharmacy and Poisons Board (PPB).
• Instructional Capacity: Proven background designing, facilitating, and assessing technical training modules and staff development programs.
• Professional Standing: Active registration or membership with relevant professional associations (e.g., Pharmacy and Poisons Board, Pharmaceutical Society of Kenya) is a distinct advantage.

Executive Leadership Traits

• Executive Presence: High level of professionalism, diplomatic negotiation capacity, and maturity to advise senior directors on compliance exposure.
• Communication Command: Exceptional oral, written, and presentation skills to deliver complex scientific and regulatory content clearly.
• Organizational Mastery: Strong multi-tasking abilities to navigate overlapping submission deadlines, audit schedules, and corporate training calendars.

What We Offer

• Strategic Influence: Take primary ownership of the regulatory roadmap and team capability development for a major pharmaceutical importer and distributor.
• Portfolio Scope: Direct market access for a diverse range of high-value human health products, life-saving therapeutics, and medical supplies.
• Leadership Visibility: Work directly alongside executive leadership and international principals, building an elite profile within the regional healthcare ecosystem.

How to Apply

Please email your CV to [insert email address] quoting "Regulatory Affairs & Training Manager" in the subject line. Applications must be received before Saturday, 25th July 2026.