Senior Regulatory Affairs Director
hace 6 días
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult 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’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. R&D Biopharma drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
What you'll 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 lead the 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, 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 skill-development, coaching, and performance feedback.
Minimum 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 face-to-face in our offices 3 days a week.
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