Regulatory Affairs Associate (Pharma)

About the role

Dawa Life Sciences is seeking a Regulatory Affairs Associate to support its pharmaceutical and animal health portfolio. The role involves preparing and managing product dossiers for African markets, ensuring compliance with local regulations, and collaborating with cross‑functional teams.

Key responsibilities

• Prepare, review, and submit product dossiers, uploading them to each authority’s portal.
• Manage variations and renew product licences to keep products on the market.
• Coordinate design and approval of packaging artwork, labels, inserts, and leaflets in line with country‑specific labelling rules.
• Collaborate with Production, PD, QA, and QC on BMRs, stability data, validation reports, and methods of analysis.
• Monitor changes in pharmaceutical regulations in Kenya and the region and advise the business.
• Serve as the primary contact for regulator queries and compile technical responses with relevant departments.
• Obtain GMP certificates and import/export permits on time and maintain audit‑ready records.

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, including dossier preparation for African markets.
• Registration with the Pharmacy and Poisons Board or a comparable professional body.
• Strong knowledge of GMP, GLP, GDP, regional regulatory portals and document management systems.
• Excellent technical writing, analytical and organizational abilities.

Required skills

• GMP
• GLP
• GDP
• Regulatory portals
• Document management systems
• Technical writing