Regulatory Affairs Lead - East Africa

Role overview

We are looking for an experienced Regulatory Affairs Lead to steer compliance and regulatory execution across East Africa. This role focuses on product registrations, submission management, coordination with health authorities, and regulatory planning that supports commercial growth. Success in the position requires strong communication, stakeholder engagement, and strategic judgement.

Key responsibilities

• Lead pharmacovigilance oversight as LPVRP for Kenya, Tanzania, Uganda, Zimbabwe, Zambia, Ethiopia, Rwanda, Burundi, Nigeria, Malawi, Ghana, and Mozambique.
• Serve as the appointed and notified QPPV for Kenya PPB, Rwanda FDA, and Zimbabwe MCAZ, where applicable.
• Own product registration and life-cycle management activities in Kenya.
• Provide oversight for product registration and life-cycle management in Tanzania, Uganda, Zambia, Rwanda, Zimbabwe, and Burundi.
• Manage the registration of both new and existing products, while keeping regulatory records current and complete.
• Make sure promotional content and marketing materials comply with Pharmacy and Poisons Board requirements.
• Act as the regional pharmacovigilance contact person for all PV activities for products where Glenmark is the marketing authorisation holder, in line with local laws, guidance, and company procedures.
• Collect, review, assess, and track adverse events, product complaints, and medical information requests.
• Maintain alignment with regional and global pharmacovigilance as well as regulatory obligations.

Qualifications

• Bachelor’s degree in pharmacy is required, along with an additional certificate, diploma, fellowship, or postgraduate study in good pharmacovigilance practices from a Pharmacy and Poisons Board-recognised institution; a master’s degree in regulatory science is an advantage.
• At least 5 years of prior industry experience in Kenya.
• The designated pharmacovigilance professional must have mandatory GVP training delivered by the MAH through accredited or recognised institutions.
• Working knowledge of applicable regional laws, guidance, and international GxP standards, including GVP and GRP, is necessary.

Additional information

This position is focused on regional regulatory leadership and requires the ability to balance compliance, documentation quality, authority interaction, and cross-country coordination. The role supports both regulatory assurance and business enablement across the East African market.