About 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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