Regulatory Affairs Pharmacist West Africa at AstraZeneca

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 will include:

• 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.

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 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

• Experience of working on cross-functional teams.
• Knowledge of the drug development processes.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

Join the fastest growing pharmaceutical in our markets, set up to fuel further growth. Be part of our shared ambition and pride: our strong heritage, our turnaround story, and early investment and commitment in International markets. There’s no better place to feel inspired and energized.

SO, WHAT’S NEXT?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

Click the link to apply no later than 22 September 2023 and we’ll be in touch as soon as we can.