Regulatory Affairs Associate (Entry Level)

About the role

The Regulatory Affairs Associate will support all activities related to product registration in assigned export markets. Based in Nairobi, the role requires on‑site work and focuses on preparing dossiers, managing submissions and ensuring compliance with pharmaceutical regulations.

Key responsibilities

• Prepare and compile registration dossiers in eCTD format for new registrations, renewals, variations and retentions across export countries.
• Manage timely preparation and submission of regulatory documents, including tender documents and responses to regulatory questionnaires.
• Ensure high accuracy and full compliance in all dossier submissions, minimizing errors during review, signing and approval stages.
• Provide prompt, accurate responses to regulatory queries after dossier submissions to support efficient product approvals.
• Proactively apply for and follow up on approvals for new product registrations, variations, renewals and retentions within the assigned markets.
• Monitor, process and track all regulatory payments to ensure timely clearance and smooth progression of registration processes.
• Maintain proper document control and filing systems so that all regulatory documents are accurately recorded, securely stored and easily retrievable.
• Safeguard regulatory records to keep them complete, organized and audit‑ready at all times.

Required profile

• Minimum of a Diploma in a science‑related field.
• At least 1 year of experience in a similar regulatory affairs role.
• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry or a related discipline is preferred.

Required skills

• Proficiency in preparing dossiers using the eCTD format.
• Strong document control and filing system management.