Regulatory Affairs Director - Oncology Cell & Gene Therapy

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. 

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 Director (RAD), Oncology Cell and Gene Therapy (CGT), provides strategic regulatory leadership to influence the development of our innovative products across all stages of development. You will play a substantial role in defining and implementing the regulatory strategy and engaging with health authorities to effectively inform our development programs. You will work on cutting-edge cell therapy products and unique pre-clinical, CMC and clinical aspects of cell therapies. You may serve as the Global Regulatory Lead (GRL) on early- or late-stage projects, or specific indications of larger programs as the regional regulatory lead. You will report to the Executive Director, Regulatory Science and may be based in South San Francisco or Gaithersburg, MD.

Primary Responsibilities

• Develop and implement regional or global strategy ensuring that it is crafted to deliver efficient action, and, in the case of marketing authorizations, with competitive labelling that is identified by the business, markets and patients.

• Lead cross functional teams in major regulatory submissions (IND/CTA/NDA/BLA), health authority interactions, responses to queries, label discussions, and securing approvals. 

• Craft the health authority engagement strategy and interaction plan, drive the formulation of the briefing document focused on strategy and scientific content, lead the team through meeting rehearsals and moderate the meeting itself. 

• When serving in the role of GRL, you will lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, labeling and members of the submission and execution team. Mentor and provide performance feedback to members of your GRST. 

• Deliver regulatory milestones with your team, including an assessment of risks and mitigations, emerging data, and the probability of success.  

Minimum Qualifications 

• Experience of a minimum of 12 years with a Bachelor's degree in life sciences, 10 years with a Master's degree, or 8 years with a PhD (which may include education and training positions) with a focus on oncology drug development.

• Demonstrated competence in regulatory affairs, including proven track record of regulatory drug development and experience with major HA interactions. 

• Experience in global IND/CTA oncology filings and support for CGT/ATMP products. 

• Ability to think strategically and critically and evaluate risks to regulatory activities.  

Desirable Skills

• Demonstrated competencies of strategic influencing, innovation and initiative. 

• Ability to operate individually and also lead matrixed, cross-functional teams.

• Experience driving global regulatory strategies in support of advancing clinical programs.

Why AstraZeneca? 

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed