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 world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.
Do you possess strategic leadership skills? Do you have an understanding of global regulatory science and the overall drug development processes and strategies? Do you influence cross-functional discussions with global teams and partners? Join us and make a difference!
Our Regulatory Affairs Director develops and implements the regulatory strategy for a product or group of products, ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.
Our Regulatory Affair Director play 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.
What You'll Need:
Bachelor's degree in a science related field and/or other appropriate knowledge/experience.
5 to 10 years of experience or equivalent of regulatory drug development including product approval/launch. Expert knowledge of regulatory affairs within one or more therapeutic areas.
Previous experience in attending and/or helping a team prepare for a Major Health Authority interactions (e.g. FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.).
Proven leadership and program management experience.
Ability to work strategically within a complex, business critical and high profile development program.
Successful contribute to a major regulatory approval at a global or regional level.
A scientific and clinical understanding of the regulatory sciences.
Excellent oral and written communication skills.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Internal Number: R-089626
We are more than 65,000 people in over 100 countries. Our aim is simple: to positively impact lives, together. Using the power of science and innovation, our people improve the impact medicine has on patients. Together, we explore the limitless world of science through our impressive product pipeline and we take our understanding of many therapeutic areas to a whole new level by seeking new treatments.With such essential, life-changing work being undertaken across the world, the range of roles we offer is extensive. From Clinical Development, Regulatory and Medical Affairs, to Finance, Manufacturing and Supply, our opportunities cover many disciplines. Here, you can explore the full potential of science while building a career that means more to you and our patients.