Position Summary

The Regulatory Affairs Associate is responsible for supporting the registration, retention, and lifecycle management of pharmaceutical products and medical consumables with relevant regulatory authorities. The role also supports pharmacovigilance activities, including adverse event reporting, safety documentation, and compliance with local regulatory requirements.

The associate will coordinate with manufacturers, distributors, PPB, and internal departments to ensure timely submissions, approvals, renewals, and regulatory compliance.

Key Responsibilities

Product Registration & Retention

• Prepare and compile regulatory dossiers for registration of medicines and medical consumables.
• Submit registration and retention applications to regulatory authorities within required timelines.
• Follow up with regulatory authorities regarding pending applications, queries, approvals, and renewals.
• Coordinate with manufacturers to obtain required technical and legal documentation.
• Ensure all registrations, licenses, and retention certificates remain valid and up to date.
• Maintain regulatory databases and tracking systems for all products.
• Monitor regulatory changes and communicate relevant updates internally.
• Ensure product labelling and packaging comply with local regulatory requirements.

Regulatory Correspondence

• Respond to deficiency letters and regulatory queries from authorities such as Kenya PPB and other regulatory bodies.
• Maintain organized records of submissions, approvals, and correspondence.
• Liaise with external consultants, agents, and manufacturers regarding regulatory matters.

Pharmacovigilance & Safety Reporting

• Collect, document, and report adverse drug reactions and safety complaints according to local pharmacovigilance requirements.
• Maintain pharmacovigilance records and safety databases.
• Coordinate timely submission of adverse event reports to regulatory authorities.
• Follow up with healthcare professionals and internal departments regarding safety information.
• Assist in implementing pharmacovigilance SOPs and compliance activities.

Compliance & Documentation

• Ensure compliance with applicable pharmaceutical regulations and company SOPs.
• Maintain updated regulatory files and product documentation.
• Assist during regulatory inspections and audits.
• Support quality assurance and commercial teams with regulatory information when required.

Qualifications

Education

• Bachelor’s degree in pharmacy, Pharmaceutical Sciences, Medicine, Chemistry, Biotechnology, or related field.

Experience

• 1–3 years of experience in regulatory affairs or pharmacovigilance preferred.
• Experience dealing with pharmaceutical registrations and retention processes is an advantage.
• Familiarity with PPB procedures is preferred.

Skills & Competencies

• Strong attention to detail and organizational skills.
• Good understanding of pharmaceutical regulatory requirements.
• Ability to manage multiple projects and deadlines.
• Strong communication and follow-up skills.
• Proficiency in Microsoft Office applications.
• Ability to work independently and collaboratively.

• Prepare and compile regulatory dossiers for registration of medicines and medical consumables.
• Submit registration and retention applications to regulatory authorities within required timelines.
• Follow up with regulatory authorities regarding pending applications, queries, approvals, and renewals.
• Coordinate with manufacturers to obtain required technical and legal documentation.
• Ensure all registrations, licenses, and retention certificates remain valid and up to date.
• Maintain regulatory databases and tracking systems for all products.
• Monitor regulatory changes and communicate relevant updates internally.
• Ensure product labelling and packaging comply with local regulatory requirements.
• Respond to deficiency letters and regulatory queries from authorities such as Kenya PPB and other regulatory bodies.
• Maintain organized records of submissions, approvals, and correspondence.
• Liaise with external consultants, agents, and manufacturers regarding regulatory matters.
• Collect, document, and report adverse drug reactions and safety complaints according to local pharmacovigilance requirements.
• Maintain pharmacovigilance records and safety databases.
• Coordinate timely submission of adverse event reports to regulatory authorities.
• Follow up with healthcare professionals and internal departments regarding safety information.
• Assist in implementing pharmacovigilance SOPs and compliance activities.
• Ensure compliance with applicable pharmaceutical regulations and company SOPs.
• Maintain updated regulatory files and product documentation.
• Assist during regulatory inspections and audits.
• Support quality assurance and commercial teams with regulatory information when required.

• Strong attention to detail and organizational skills.
• Good understanding of pharmaceutical regulatory requirements.
• Ability to manage multiple projects and deadlines.
• Strong communication and follow-up skills.
• Proficiency in Microsoft Office applications.
• Ability to work independently and collaboratively.

• Bachelor’s degree in pharmacy, Pharmaceutical Sciences, Medicine, Chemistry, Biotechnology, or related field.
• 1–3 years of experience in regulatory affairs or pharmacovigilance preferred.
• Experience dealing with pharmaceutical registrations and retention processes is an advantage.
• Familiarity with PPB procedures is preferred.