Harley’s Limited is a company registered in 1953 that deals in the sales, marketing and distribution of healthcare products, pharmaceuticals, surgical-equipment, medical equipment, ophthalmic equipment, theatre equipment and OTC products. The volume of business generated since the current management took over from 1975 has continued to grow steadily. At th...
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New Product Registration Submissions (Pharmaceuticals & Medical Devices): Prepare, compile, review and submit high-quality dossiers (e.g., eCTD format) for new product registrations to national and regional regulatory authorities. Develop regulatory strategies for new products to ensure the fastest possible time to market while maintaining compliance. Coordinate with suppliers for all required documentation in line with PPB guidelines.
Maintenance and Lifecycle Management: Manage the timely preparation and submission of license renewals for existing products registrations to prevent market disruptions. Handle amendments to existing Marketing Authorizations (MAs) due to changes in manufacturing, labelling, or other factors.
Regulatory Authorities Liaison and Follow-up: Assist in follow-ups and communication with the Pharmacy and Poisons Board (PPB). Coordinate and prepare timely responses to regulatory queries, deficiency letters and requests for additional information from authorities.
Imports/Exports Regulatory Compliance: Support the application and tracking of import and export permits for all products. Ensure all product packaging, labelling and Patient Information Leaflets (PILs) comply with local regulatory standards and approved artworks.
Regulatory Intelligence and Compliance: Monitor changes in the national and international regulatory landscape (e.g., changes to registration requirements) and communicate the impact to relevant internal stakeholders.
Products Advertisement & Promotional Materials: Manage the timely preparation, submission and follow-ups of products advertisements and promotional materials approvals with the regulatory authorities.
Compliance and Governance: Ensure compliance and governance with relevant policies and procedures.
QUALIFICATIONS & EXPERIENCE
Diploma or Bachelor’s Degree in Life Sciences, Chemistry or a related scientific discipline.
5 years of experience in Regulatory Affairs, preferably within the Pharmaceutical & Medical Device industry.
Demonstrated experience in the preparation, review and successful submission of new product registrations dossiers and managing license renewals/variations.
Solid understanding of regulatory guidelines within East Africa.
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