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Head of Regulatory ICA - Oncology

Местоположение Гейтерсберг, Мэриленд, США Идентификатор вакансии R-101323 Дата публикации 02/25/2021

We are actively seeking a Head of Regulatory ICA (Immuno-Oncology Cell Therapy & Antibody Drug Conjugates) to help lead a vertical of AstraZeneca’s Oncology Regulatory Science & Strategy group. Are you a dynamic, collaborative leader with expertise in the Oncology regulatory affairs space? Are you future-oriented with a global mind-set, motivated to lead a team who will provide global strategic regulatory oversight? Then this role may be for you!

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.

Within Oncology Regulatory Science & Strategy, we work in areas of unmet needs and take innovative regulatory approaches to bring life-changing treatments to those who need it – working across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. As an industry leading Oncology Regulatory function, we’re growing fast and we’re as focused and committed to the development of our people as we are our business – providing an open and supportive space to explore, learn, grow and develop across all roles and levels.

The Regulatory Head ICA (delivers Immuno-oncology agents, Cell therapies and Antibody-drug conjugates) within our Oncology Regulatory Science & Strategy (ORSS) business. With responsibility for a very large portion of the portfolio, you will partner with the SVP ORSS, the ORSS Leadership Team, and other R&D and Business functions to provide at critical milestones strategic guidance within the framework of AZ governance for the portfolio pillars and development programs. To achieve that, the position is responsible for leading and managing Executive Directors and Global Regulatory Leaders assigned to AZ development programs.

In this capacity, you will provide global strategic regulatory expertise and oversight to support the research, development and commercialisation of products across both small molecules and biologics within the Oncology Regulatory Science and Strategy (ORSS) group.

How you will make a difference:

  • Be a key member of the ORSS Leadership Team (LT) for the long term strategy of the function. Develop and implement a joint vision within ORSS LT.
  • Responsible for the ORSS Regional Centre of Excellence.
  • Deputise for the SVP ORSS when required.
  • Development and alignment of dedicated global regulatory strategies for the assigned programs in line with the strategic priorities of the therapy area, as well longer-term investments
  • Collaborate within ORSS on the development of the digital strategy for the area of interest
  • Specific focus on people management and development, including succession planning
  • Ensure regulatory perspective is included in TA business decisions including portfolio management for the areas of interest
  • Align with Regulatory Business Development and the SVP on in-or-out licensing opportunity/external collaborations
  • Use Regulatory Intelligence to monitor changes in the TA regulatory environment
  • Represent AZ outside of the company (e.g. DIA, Trade Association Meetings) and build a network of regulatory contacts
  • Review and approve submission documents for the portfolio areas of interest
  • Ensure best practice is shared within the TA and across the TA groups and ensure adherence to company policies and procedures

What You'll Need:

  • PhD in scientific discipline or equivalent.
  • 15 years’ global experience or equivalent of delivering positive global outcomes, across a portfolio of products, on programs varying in scientific & clinical complexity including product approval/launch, with experience and knowledge in Oncology
  • Broad Experience in drug development
  • Strong people and project management experience
  • Successful contribution to a wide range of regulatory approvals either at regional or global level.
  • Demonstrated track record in Portfolio & People Leadership from a Regulatory Sciences perspective
  • Established and recognized influential relationships with global health authorities in respective disease or therapeutic area (TA).
  • Served on key governance committees that are relevant for  the area of interest
  • Experience leading global functional teams, managing change and building regulatory sciences & disease area capabilities within the function
  • Ability to manage the budget of the area of interest (can be 10M$ or more), and contribute to the financial plan for ORSS

Next steps, if the role looks suitable please apply!

Location: Gaithersburg, US

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 authorisation and employment eligibility verification requirements.

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