Regulatory Affairs Pharmacist, West Africa at AstraZeneca

Posted on: Tue 19-09-2023

AstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.

We are recruiting to fill the position below:

Job Title: Regulatory Affairs Pharmacist, West Africa

Job Requisition ID: R-180143

Location: Lagos

Job Type: Full time

About Our Sub Sahara Regulatory Affairs Team

Across our diverse group of markets, we bring transformative products to the market, to ultimately transform the lives of people living with serious diseases.
Leaders in the market, we utilize our large data sets and scientific backing, to influence opinion leaders and key stakeholders. Adapting and transforming each unique healthcare system in our markets.
Our AfriCAN Cluster Regulatory Affairs team is successful and committed to everyday excellence. We put the patient first in every decision we make. Compliance is at the heart of all we do.
Collaboration within the team, the wider cross functional team and industry bodies is key to our success.

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

Provide regular feedback to Head Of Regulatory, 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.

Essential Skills & Experience Required?

Essential:

Bachelor’s Degree in Pharmacy. Advanced degree a plus.
Valid Superintendent Pharmacist License.
Experience in managing Mauritius and Zimbabwe is a plus.
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: