Haleon plc is a British multinational consumer healthcare company with headquarters in Weybridge, Surrey. It is the largest consumer healthcare business in the world, with brands including Sensodyne toothpaste, Panadol and Advil painkillers and Centrum vitaminsAbout the role Regulatory Affairs Support in East Africa through: To maintain the relevant Global and local Regulatory and compliance databases Management of regulatory repository(archiving) Support of life cycle management through submission of renewals, variations and re-registration and retentions. Preparation and submission of promotional materials and samples Support the registration of new products in East Africa Management of registration samples CPPs and COAs Supporting the tender business by providing the updated documentation needed for tender. Key responsibilities Submission of variations e.g. source changes, pack amendments, shelf- life extensions, formulation and finished products specifications changes Maintains databases and relevant trackers with registered product information e.g. Update Veeva for variations, notifications, queries and commitments Maintains product registrations by ensuring re-registrations are done on time and notifications to changes on the registered details are also done in a timely manner Follow up of on the health authority regulatory systems update Maintenance of the payment reconciliation trackers for East Africa Coordinate dispatch of documents and samples within Haleon and from the company to the various health authorities in East Africa Provide the tender team with any regulatory documentation needed when tenders are floated Archiving champion: ensure all documents in East Africa are archived in the right format and repository Regulatory Samples coordinator and maintenance of an up-to-date samples database Support in MM audits and CAPA/Action Item closure Completes any other regulatory responsibility assigned by the Head of department/Supervisor Owns price setup and maintenance process Qualifications and skills Required Bachelor of Pharmacy Working experience of 3 years in pharmaceutical regulatory environment. Knowledge of regulatory requirements and product registration Other Skills/Qualifications Good interpersonal skills, high integrity and ability to engage in ethical conversations are pre- requisite. Excellent communication skills Good team player Knowledge and experience of Regulatory Affairs in markets in Eastern Africa Added knowledge in other SSA markets would be an added advantage Provide regulatory support to stakeholders as appropriate within the organization Requires understanding of how to quickly resolve issues around logistics and permit applications and approvals Requires proper planning and coordination to ensure timelines are maintained Ability to work well under pressure and still maintain sound balance in decision making Ability to meet the deadlines for the strategic and tactical plans
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