Regulatory Affairs Associate

About the role

The Regulatory Affairs Associate will support Dawa Life Sciences in maintaining product registrations across African markets, ensuring compliance with local regulations and facilitating timely market access.

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 main contact for regulators, providing clear technical responses.
• Obtain GMP certificates and import/export permits, maintaining 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 relevant professional body.
• Strong technical writing, communication, analytical and organisational abilities.

Required skills

• Good knowledge of GMP, GLP and GDP.
• Experience with regional regulatory portals and document management systems.
• Technical writing and dossier preparation.