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Head of Regulatory Affairs, African Cluster

3 months ago

Johannesburg, Gauteng, South Africa AstraZeneca Full time
Do you have expertise in and a passion for science _and innovation through medicine, working in Regulatory Affairs leading a regulatory team to long-term success, and creating value for our patients through timeous submissions, accelerated approval and regulatory authority relationship and capability building? If so, AstraZeneca might be the one for you_

ABOUT ASTRAZENECA


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 diseases.

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. Our strategic priorities reflect how we are working to deliver our strategy and achieve our Purpose.

As a workforce, we are the catalyst for our values:

we are entrepreneurial; we do the right thing; we play to win; we put patients first and we follow the science.

As a company we appreciate and take great pride in each team member where every person is brought together through shared values, that underpins a shared purpose.

There's no better place to feel inspired and energized.

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. 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.

ABOUT OUR REGULATORY AFFAIRS TEAM
The Regulatory Team is a team driven by high performance and a product portfolio growth mindset.

The team prides itself in being a team that has well-demonstrated resilience, tenacity to achieve success, a winning attitude, quality submissions, robust systems, accelerated approvals, efficient collaboration and communication, to do the right thing and to execute with excellence and to deliver impactful results.

Patient centricity is the driving force behind every interaction the team undertakes. Life-long learning and continuous coaching are part of our make-up. We have a bold ambition to be market leaders in all therapeutic areas across all territories in our regions.

A high-performance culture is embedded and entrenched across all teams, enterprise matrix and collaborations are part of our everyday working at AstraZeneca, ensuring that it is through a unified approach that we can achieve more.


What you'll do?


Provides strategic and operational regulatory leadership to the development, commercialisation and life cycle management of the assigned product(s) in product teams.

Applies knowledge of current local and global Regulatory trends to identify future regulatory requirements and strategies. Influences Regulatory authorities through regular contacts to improve Regulatory outcomes. Responsible for the management of a skill group such as CMC, Regulatory affairs project management, etc. Responsible for skill development, performance management, and resource allocation.

Typical Accountabilities

  • Provides effective lobbying and influencing on regulatory agencies and trade associations on product and legislative development issues and monitors changes in the regulatory environment in nominated region to support and advise relevant functions.
  • Provides strategic regulatory advice support for product developments regional therapy area
  • Represents AZRA on relevant external Trade Association committees to ensure AZ RA and/or AZ views on key issues are known
  • Ensures adequate risk assessments and mitigation plans are included in the regulatory strategy documents
  • Contribute effectively to Global Development programmes, providing expert advice and interpretive inputs on market legislation and requirements that impact on new and existing product registrations
  • Ensures effective collaboration across the global, regional and local Regulatory Affairs interface enabling rapid and effective submissions, approvals and other product maintenance activities
  • Participates in skilldevelopment, coaching, and performance feedback of other regulatory staff working on the product/project
  • Ensures all markets remain in compliance with product licenses maintained and ensuring improvement plans are in place to close compliance gaps. Provide support and advice on training and development to ensure all regulatory personnel in markets have an appropriate knowledge of quality and compliance
  • Has personal responsibility for crea