Regulatory Affairs Associates

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.
  

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