Regulatory Affairs Pharmacist

About the Role

This is a Regulatory Affairs Support position covering East Africa. The role is responsible for maintaining global and local regulatory and compliance databases, managing the regulatory repository (archiving), supporting life cycle management through timely submissions of renewals, variations, re-registrations, and retentions. It also involves preparing and submitting promotional materials and samples, supporting the registration of new products in East Africa, managing registration samples such as CPPs and COAs, and supporting the tender business by providing updated documentation needed for tender submissions.

Key Responsibilities

• Submit variations, including source changes, pack amendments, shelf-life extensions, and changes to formulation and finished product specifications.
• Maintain databases and relevant trackers with registered product information, such as updating Veeva for variations, notifications, queries, and commitments.
• Ensure product registrations are maintained by completing re-registrations on time and notifying changes to registered details in a timely manner.
• Follow up on health authority regulatory system updates.
• Maintain payment reconciliation trackers for East Africa.
• Coordinate dispatch of documents and samples within Haleon and from the company to various health authorities in East Africa.
• Provide the tender team with any regulatory documentation needed when tenders are floated.
• Act as archiving champion, ensuring all documents in East Africa are archived in the correct format and repository.
• Serve as Regulatory Samples coordinator and maintain an up-to-date samples database.
• Support in MM audits and CAPA/Action Item closure.
• Complete any other regulatory responsibility assigned by the Head of Department/Supervisor.
• Own the price setup and maintenance process.

Qualifications and Skills

Required

• Bachelor of Pharmacy
• 3 years of working experience in a 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.
• Excellent communication skills.
• Good team player.
• Knowledge and experience of Regulatory Affairs in markets in Eastern Africa; added knowledge in other SSA markets is an advantage.
• Ability to 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 while maintaining sound balance in decision making.
• Ability to meet deadlines for strategic and tactical plans.