Regulatory Affairs Pharmacist – Diagnostics

About the role

A global healthcare and diagnostics company is looking for a Regulatory Affairs Pharmacist to support regulatory activities across East Africa. The role suits someone with strong experience in diagnostics, medical devices or in vitro diagnostics (IVD) who wants to ensure regulatory compliance, speed up market access and support healthcare innovation. Immediate availability or short-notice start is preferred.

Key responsibilities

• Develop and run regulatory strategies for diagnostic products across East African markets, monitor regulatory changes and support advocacy with health authorities and industry stakeholders.
• Prepare and submit regulatory dossiers and registration applications, manage approvals, renewals and variations, and keep accurate records of licenses and expiry dates.
• Support tenders, technical evaluations and health technology assessments, and assist product launches and market entry.
• Ensure compliance with vigilance, post-market surveillance, complaints and recalls, support QMS and regulatory SOPs, and help with incident reporting and field actions.
• Support regulatory inspections and audits, and build relationships with regulators, ministries of health, distributors and industry associations.
• Deliver regulatory guidance and training to associates, distributors and partners, and work with Quality, Medical Affairs, Marketing, Supply Chain and Commercial teams.

Required profile

• Bachelor's degree in Pharmacy, Life Sciences or Biomedical Sciences, with relevant and updated licenses and registrations.
• At least 3 years of regulatory affairs experience in medical devices, IVD, diagnostics, healthcare or pharmaceuticals, including managing regulatory submissions and registrations.
• Experience with East African regulatory authorities and frameworks; exposure to vigilance, post-market surveillance and quality systems is an advantage.
• Fluent English and strong communication and stakeholder management skills.

Required skills

• Knowledge of medical device and IVD regulatory frameworks and product registration processes across East Africa.
• Understanding of quality management systems and vigilance requirements.
• Project management, attention to detail and proficiency in Microsoft Office and regulatory management systems.