Regulatory Affairs Associates
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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-ready.
Qualifications and Experience:
Ideal Candidate Requirements
- To 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.