Background information about the job or company (e.g., role context, company overview)

We are continuously upgrading to new technologies and implementing robust processes to ensure we deliver best-in-quality products to our communities

Responsibilities or duties

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 or requirements (e.g., education, skills)

Diploma or bachelor’s degree in pharmacy (B.Pharm), Chemistry, Industrial Chemistry, Biochemistry, Pharmaceutical Sciences, or related science.

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.

Experience needed

4–5 years’ Regulatory Affairs experience in pharmaceutical manufacturing, including preparing dossiers for African markets.

• 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.

• Strong technical writing skills
• Communication skills
• Teamwork skills
• Analytical ability
• Organizational ability
• Good knowledge of GMP, GLP, and GDP
• Good knowledge of regional regulatory portals and document management systems

• Diploma or bachelor’s degree in pharmacy (B.Pharm), Chemistry, Industrial Chemistry, Biochemistry, Pharmaceutical Sciences, or related science.
• Registration with the Pharmacy and Poisons Board or a relevant professional body.