Senior Regulatory Affairs Director - Oncology Cell and Gene Therapy at AstraZeneca in Gaithersburg, Maryland

Job Description:

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious disease. AstraZeneca's pipeline of industry-leading innovative medicines is consistently growing, and we are investing in our capabilities to become leaders in the delivery of next-generation cell and gene therapies. At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.



Oncology Regulatory Science and Strategy



We are recruiting Regulatory Affairs professionals to join the Oncology Regulatory Science and Strategy (ORSS) team. As Regulatory professionals working on Oncology products, we take innovative regulatory approaches to get medicines to patients as efficiently and effectively as possible.



The Regulatory Affairs Senior Director (SRAD), Oncology Cell and Gene Therapy provides strategic regulatory leadership to influence the development of our innovative products across all stages of development. The SRAD is 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 labelling 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.



What you'll do

• Represent regulatory on cross-functional project development teams.
  
  


• Be accountable for the delivery of regulatory milestones for products across the phases of drug development.
  
  


• Lead the planning and construction of the global dossier and core prescribing information.
  
  


• Conduct regulatory risk planning and identify mitigation strategies, analysis of the probability of regulatory success
  
  


• Lead the objective assessment of emerging data against product development plans.
  
  


• Lead the Global Regulatory Sub-Team (GRST) with key contributing members from a regional perspective, emerging markets, RA CMC, translational regulatory, and delivery & enablement. In addition to providing leadership to the GRST, you will participate in skill-development of GRST members.
  
  

Minimum Qualifications:

• An advanced degree in a science related field and/or other appropriate knowledge/experience. Total of 9 years of experience, which may include education and training positions.
  
  


• Broad experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
  
  


• Demonstrated experience in global development of CGT/ATMP products.
  
  


• An understanding of oncology drug development.
  
  


• Previous experience leading major health authority interactions.
  
  


• Knowledge and understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.
  
  


• Demonstrated competency in strategic thinking, strategic influencing, innovation and leadership.
  
  


• Excellent oral and written communication skills.
  
  


• Successful contribution to a major regulatory approval, including negotiation of prescribing information and prescribing information is preferred.
  
  

Why AstraZeneca?



At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering ground-breaking methods and bringing unexpected teams together. Interested? Come and join our journey.



So, what's next!



Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.



Where can I find out more?



Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/


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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Apply Now