Senior Regulatory Affairs Director
Senior Regulatory Affairs Director
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Job Description
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue worldclass medicines in new ways combining our peoples exceptional skills with those of people from all over the globe.
As a Senior Regulatory Affairs Director youll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients lives. R&D Biopharma drives latestage development of our innovative pipeline transforming exciting science into valued new medicines and ensuring patients around the world can access them.
What youll do:
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 with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business markets and 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 will leads the Global Regulatory Subteam (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 supply and 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 marketing company and regional regulatory affairs staff to influence developing views/guidance. You will lead the regulatory staff working provide leadership and participate in skilldevelopment coaching and performance feedback.
Essential Requirements:
- Advanced degree in a science related field and/or other appropriate knowledge/experience.
- Must have previous experience in leading Major Health Authority interactions.
- Significant experience or equivalent of regulatory drug development including product approval/launch.
- Expert knowledge of regulatory affairs within one or more therapeutic areas.
- Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
- Experience in relevant therapy area (small molecules & biologics) is preferred.
- Proven leadership and program management experience.
- Ability to think strategically and critically evaluate risks to regulatory activities.
- Ability to work strategically within a complex business critical and high profile development program.
- Successful contribution to a major regulatory approval at a global level.
- A scientific and clinical understanding of the regulatory sciences.
- Must demonstrate competencies of: strategic thinking strategic influencing innovation initiative leadership and excellent oral and written communication skills.
Recognizing the importance of individualized flexibility our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging facetoface in our offices 3 days a week.
Date Posted
02May2025Closing Date
30May2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion starting with our recruitment process. We welcome and consider applications from all qualified candidates regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations please complete the section in the application form.Required Experience:
Director
Employment Type
Full-Time
