Senior Regulatory Affairs Director

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges.

We do this with theupmostintegrity even in the mostdifficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world‑class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

As a
Senior Regulatory Affairs Director
you’llplay a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

R&D Oncology drives late‑stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.

As the Senior Regulatory Affairs Director you will be accountable for leading the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity. You will ensure that the strategy is designed to deliver rapid approval withadvantageouslabeling in keeping with the properties of the product(s) and the needsidentifiedby the business,market sand patients. You will show strategic leadership skills, and a deep understanding of global regulatory science and overall drug/biologic development processes and strategies for high profile, complex or novel development programs.

You will lead the planning and construction of the global dossier and core prescribing information. You will conduct regulatory risk planning and mitigation. You willleadsthe Global Regulatory Sub-team (GRST) with key contributing members from a regional perspective, emerging markets, RA CMC as well as delivery & enablement. You will be accountable for the delivery of all regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures.

You will be accountable for product maintenance,supplyand compliance activities associated with marketed brands.

You will lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities. You will partner with marketingcompanyand regional regulatory affairs staff to influence developing views/guidance.

You will lead the regulatory staff working, provide leadership andparticipatein skill-development, coaching, and performance feedback.

• Accountable for leading the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.
• Ensure that the regulatory strategy is designed to deliver rapid approval withadvantageouslabelingin keeping with the properties of the product(s) and the needsidentifiedby the business,market sand patients.
• Demonstrate strategic leadership skills, and a deep understanding of global regulatory science and overall drug/biologic development processes and strategies for high profile, complex or novel development programs.
• Lead the planning and construction of the global dossier and core prescribing information, conduct regulatory risk planning and mitigation, and lead the Global Regulatory Sub-team (GRST) with key contributing members from a regional perspective, emerging markets, RA CMC as well as delivery & enablement.
• Accountable for the delivery of all regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures, potentially including product maintenance, supply and compliance activities associated with marketed brands.
• Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
• Partner with marketing company and regional regulatory…