What you’ll do?
As the successful candidate, you will have an opportunity to work with a passionate team of individuals dedicated to accelerating access to life-changing & innovative medicines for our patients. In addition, gain exposure and network to Health Authority regulatory framework across the various SSA countries within the African Cluster. Prepare regulatory submissions for allocated products according to the agreed regulatory strategy to develop and maintain products. You will provide scientifically related guidance to cross functional teams on aspects of regulatory affairs. Use knowledge and experience in the regulatory field to influence functional objectives.
Typical accountabilities will include:
Provide regular feedback to senior regulatory affairs manager SSA, marketing, and sales teams on the regulatory submission progress of specific products and ensure that all teams have up to date regulatory information and support needed to drive performance in their respective departments.
Submit Marketing Authorization: applications to Health Authorities according to SSA HA guidelines and GRP, in the shortest possible time based on business priorities.
Ensure all post approval product maintenance activities including CMC variations, package insert safety updates, new indications, technical changes to the label or the packs, PBRERs, and post approval commitments are submitted and approved.
Ensure all License Renewals are submitted on time, prior to license expiry or in accordance with the planned submission date.
Participates as a member of the drug project team to assist in the delivery of timely approvals and advantageous product information in keeping with the needs identified by the business and markets and in compliance with relevant AstraZeneca procedures.
Contributes to the planning, preparation (including authoring) and delivery of simple submissions and contribute to more complex ones, from either a global and or regional perspective throughout the product’s life cycle.
Liaises proactively with the functions and participate as a member of cross-functional delivery teams, providing regulatory advice on simple regulatory issues.
Contributes, where appropriate, to the review of cross-functional contributions and collate regulatory comments to ensure quality of documentation for submission.
Provides local regulatory authority contact or support for such.
Ensures that appropriate, up-to-date records are maintained for compliance.
Has personal responsibility for creating a culture of courageous leadership, creativity, and collaboration.
If this sounds appealing, please read on to understand the experience and skills we’re looking for…
ESSENTIAL SKILLS & EXPERIENCE REQUIRED?
Essential
Bachelor’s Degree in Pharmacy. Advanced degree a plus.
Valid and available Annual Practice License for the Pharmacist.
Registered with Pharmacy and Poisons Board.
Significant experience of working in one or more areas in regulatory affairs in the pharmaceutical or related industry, or in regulatory drug development, product approval/launch, line extension and license maintenance, or experience at a health authority.
Project and process management.
Desirable
Experience of working on cross-functional teams.
Knowledge of the drug development processes.
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