Regulatory Affairs Pharmacist - AstraZeneca

Regulatory Affairs Pharmacist - AstraZeneca

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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.

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. Always committed to lifelong learning, growth, and development.

ABOUT OUR REGULATORY 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. Provides scientifically related guidance to cross functional teams on aspects of regulatory affairs. Uses knowledge and experience in the regulatory field to influence functional objectives.

Some areas of focus for this role 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?

• Bachelor’s degree in pharmacy. Advanced degree is a plus.
• Experience of drug development in the pharmaceutical industry.
• Experience of working on cross-functional teams.
• Expertise in Information and document management technology and electronic/paper publishing software.
• Excellent written and verbal communication skills.
• Thorough knowledge of world-wide Health Authority requirements on Regulatory technical format including processes and technologies.
• Resource Management skills.
• Influencing and negotiating skills.

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