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Executive Regulatory Science Director - Oncology

Местоположение Гейтерсберг, Мэриленд, США Кембридж, Англия, Великобритания Идентификатор вакансии R-122772 Дата публикации 10/29/2021

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 and Senior 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 with 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 and mitigations 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 marketing applicationsprojects including sharing the best submission practises and knowledge and using existing tools.
  • The role will involve oversight of early/innovative projects

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.

Preferred:

  • Advanced degree in a scientific subject area (e.g. MSc, PhD, PharmD, MD)
  • Experience in regulatory oncology cell therapy and/or immuno-oncology

Location: Gaithersburg or Waltham Boston or New York US (US sites preferred) or Cambridge UK

Salary: Competitive + Excellent Benefits

Closing Date: 23rd December 2021

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

Where can I find out more?

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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 authorisation and employment eligibility verification requirements.

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