Regulatory Affairs Associates
First seen by Alion on Oct 20, 2026.
ABOUT THE COMPANY
A Life Sciences company with core competencies in health care. Since 1994, through our businesses, we pursue our core purpose of providing a better quality of life for all in communities across the region by providing better medication for humans and animals (Pharmaceutical and Animal Health) and supporting high-quality food and water supply (Chemicals).
JOB SUMMARY
Qualifications and Experience:Ideal Candidate RequirementsTo be highly considered, these minimum requirements must be evident on your resume.Diploma or bachelor’s degree in pharmacy (B.Pharm), Chemistry, Industrial Chemistry, Biochemistry, Pharmaceutical Sciences, or related science.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.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 our 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 our filings match what we actually do.Follow changes in pharmaceutical regulations in Kenya and the region and advise the business early on what they mean for us.Be the main contact for questions from regulators and pull together clear technical responses with the relevant departments.Obtain GMP certificates and import/export permits on time and keep all records audit-readySend CV and Cover Letter to [email protected]
REQUIRED SKILLS
Quality management, Product management, Production, Supervision
REQUIRED EDUCATION
Diploma, Associate's degree