Vacancies at AstraZeneca

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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What you’ll do?

The Business Insights Manager will plan, direct, and oversee a wide range of analyses, related to the current and future business of the organization and proactively interact with senior commercial leaders to ensure sustainable performance over time. Through partnering within the commercial team, you will aid in managing risks and opportunities as well as strategic decisions through leveraging business insights and competitive / market intelligence.

Some areas of focus for this role will include:

• Proactively identify business information needs/issues.
• Provide brand / market evaluation and interpretation and provide business insights and competitive / market intelligence in aiding strategy decisions by using internal and external datasets.
• Leads the Operational Planning Process, providing analytical expertise to the commercial teams, driving strategic and operational excellence.
• Prepares outputs of the process and participates in presentations and recommendations to leadership through data interpretation, visualization, and insight generation to support business critical decisions.
• Leads the portfolio prioritization process within the brand team and in support of the TA.
• Support launch excellence processes for new products / indications from commercial perspective, managing forecasting models to support in-market cases / new product launch viability.
• Leads patient flow modelling and patient analytics. 
• Partner with the commercial team, producing brand volume forecasts, consulting with the team to manage risks and opportunities for the business, leading to objective and accurate forecasts supported by insight & analytics.
• Develop and maintain market research budgets for the brand team, also determining primary market research design and overseeing project / vendor management when needed.

If this sounds appealing, please read on to understand the experience and skills we’re looking for…

ESSENTIAL SKILLS and EXPERIENCE REQUIRED

• Business Degree.
• Pharmaceutical marketing and/or sales experience.
• Thorough understanding of the pharmaceutical business (including commercial and development).
• Understanding of the drug development process.
• Comfort with ambiguity/uncertainty and ability to lead teams through situations by providing clarity, structure and focus.
• Knowledge of strategic planning processes and tools.
• Excellent strategic thinking & influencing skills, understanding of forecasts, budgets, financial processes and tools, project management skills and strong interpersonal, communication (written and oral), organizational, relationship building, and consulting skills.
• Cross-functional team experience.
• Strategic influencing skills Analytical thinking skills.