Executive Regulatory Science Director - Oncology

6 days left

Maryland, USA, Gaithersburg / England, Cambridgeshire, Cambridge
28 May 2021
25 Jun 2021
AstraZeneca UK
Regulatory Affairs
Full Time
Contract Type
Experience Level
Senior Management

Are you a strategically focussed Regulatory professional with global leadership experience and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on...

At AstraZeneca work with diverse minds, all united by a shared passion to learn, grow and discover.

Within Oncology Regulatory Science and Strategy (ORSS) we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.

The Executive Regulatory Science Director, Oncology provides 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:
  • Partner with and mentor the Regulatory Affairs Directors aligning on global innovative regulatory strategies for products.
  • Provide critical review and input on disease area and portfolio regulatory strategies, risk planning and mitigations.
  • Effectively represent the Global Regulatory Affairs function in senior level interactions at internally governance technical review committees, key global health authority meetings and external partners.
  • Collaborate with regional policy and intelligence groups to critically analyse the assessment of emerging science, data and changes in the regulatory environment and advise senior management on project risks/mitigation activities accordingly.
  • Define and drive disease area global regulatory policies and priorities.
  • Lead budget management, resource planning and recruitment of staff.
  • Review and approve high-level documents for global regulatory submissions as well as core prescribing information.
  • Ensure submission excellence framework is timely and consistently applied across projects including sharing the best submission practises and knowledge and using existing tools.

What You'll Need:
  • Bachelor's degree in life sciences and/or science related field and/or other appropriate knowledge/experience.
  • Previous demonstrated drug development experience.
  • Oncology therapy area knowledge/experience.
  • Experience in global regulatory strategy and submissions that have progressed through to registration.
  • Significant experience in leading major health Authority interactions
  • Broad background of experience working in pharmaceutical/medical industry and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.
  • Experience in managing people both directly and in a matrixed organisational structure.
  • Ability to think strategically and critically to evaluate risks to regulatory product development and approval, market entry and license maintenance activities.
  • Ability to travel domestically and internationally.

  • Advanced degree in a scientific subject area (e.g. MSc, PhD, PharmD, MD)

Location: Cambridge, UK or Gaithersburg, US

Salary: Competitive + Excellent Benefits

Closing Date: 25th June 2021

Next steps, if the role looks suitable for you please apply!

Where can I find out more?

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