Regulatory Affairs Pharmacist

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