Detail

Salary
negotiable
Location
Gaithersburg, MD, USA
Posted by: Astra Zeneca
01 May
11 Views
30 Jun expires

Executive Regulatory Science Director - Oncology

Gaithersburg, MD, USA
Job Description

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.



Job ID Reference
1502
Desired Skills & Experience
  • 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.
Company
  Gaithersburg, Maryland, USA
  www.astrazeneca.com
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.
  Workplace
 Gaithersburg, MD, USA