Regulatory Affairs Associates

Dawa Life Sciences is continuously upgrading to new technologies and implementing robust processes to ensure the delivery of best-in-quality products to communities. The Regulatory Affairs Associate will be responsible for preparing and submitting regulatory filings, managing licence renewals, ensuring compliance with regional packaging and labeling rules, and serving as the primary liaison with pharmaceutical regulatory bodies.

Key Responsibilities

• Prepare, review, and submit product dossiers, and upload them correctly on each authority’s portal.
• Manage variations and renew product licences on time so products stay on the market.
• Coordinate the design and approval of packaging artwork, labels, inserts, and leaflets, making sure each country’s labelling rules are met.
• Work with Production, PD, QA, and QC on BMRs, stability data, validation reports, and Methods of Analysis so filings match operational practices.
• Follow changes in pharmaceutical regulations in Kenya and the region and advise the business early on what they mean.
• Be the main contact for questions from regulators and pull together clear technical responses with relevant departments.
• Obtain GMP certificates and import/export permits on time and keep all records audit-ready.

Qualifications and Experience

• Diploma or bachelor’s degree in Pharmacy (B.Pharm), Chemistry, Industrial Chemistry, Biochemistry, Pharmaceutical Sciences, or related science field.
• 4–5 years’ Regulatory Affairs experience in pharmaceutical manufacturing, including preparing dossiers for African markets.
• Registration with the Pharmacy and Poisons Board or a relevant professional body.
• Good knowledge of GMP, GLP, and GDP, and of regional regulatory portals and document management systems.
• Strong technical writing, communication, and teamwork skills, with good analytical and organizational ability.

How to Apply

Send CV and Cover Letter to careers@dawalifesciences.com by Wednesday, 12th August 2026.