Regulatory Affairs Pharmacist Job Haleon
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
- Agility in
- 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.
How to Apply
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