Regulatory Affairs Associate

About the role

Dawa Life Sciences is seeking a Regulatory Affairs Associate to lead the preparation, submission and maintenance of product dossiers for African markets. You will act as the primary liaison with regulatory authorities, ensuring our pharmaceutical products remain compliant and market‑ready.

Key responsibilities

• Prepare, review and submit product dossiers through each authority’s portal.
• Manage variations, renew licences and maintain audit‑ready records.
• Coordinate packaging artwork, labels, inserts and leaflets to meet country‑specific labeling rules.
• Collaborate with Production, PD, QA and QC on BMRs, stability data, validation reports and methods of analysis.
• Monitor changes in Kenyan and regional pharmaceutical regulations and advise the business.
• Respond to regulator queries and compile technical responses with relevant departments.
• Obtain GMP certificates and import/export permits on schedule.

Required profile

• Diploma or bachelor’s degree in Pharmacy, Chemistry, Biochemistry, Pharmaceutical Sciences or related field.
• 4–5 years of regulatory affairs experience in pharmaceutical manufacturing.
• Registration with the Pharmacy and Poisons Board or a comparable professional body.
• Strong analytical, organizational and teamwork abilities.

Required skills

• Good knowledge of GMP, GLP and GDP.
• Experience with regional regulatory portals and document management systems.
• Technical writing for regulatory submissions.
• Product dossier preparation and submission.
• Packaging artwork and labeling compliance.
• Stability data analysis, validation reporting and methods of analysis.