Executive Director, Regulatory Affairs - Oncology

Gaithersburg, Maryland

Posted in Pharmaceuticals
about 1 month ago

This job has expired.

Job Info

Within Oncology Regulatory Affairs, 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.

At AstraZeneca, we share and are motivated by the same purpose: pushing the boundaries of science in order to deliver life-changing medicines to patients around the world. In short, our work has true meaning! Everything we do is underpinned by our dedication to being a Great Place to Work. We recognise that our people are our greatest asset and know what's possible with an accomplished and diverse team that believes in what science can do. That's life at AstraZeneca!

We are more than 65,000 people in over 100 countries. Our aim is simple: to positively impact lives, together. Using the power of science and innovation, our people improve the impact medicine has on patients. Together, we explore the limitless world of science through our remarkable product pipeline and we take our understanding of many therapeutic areas to a whole new level by seeking new treatments.

The Executive Regulatory Science Director provides global strategic regulatory expertise and oversight to support the research, development and commercialisation of products across both small molecules and biologics.

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.
  • Significant 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 in a matrixed organizational 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)

At AstraZeneca, we have developed an offering which is competitive, compelling and aligned to our business performance; whilst supporting a culture where everyone feels valued, included and connected. As the world of work changes, our approach to reward and inclusion continues to evolve. Today, our vision and purpose is clear: together, we create rewarding experiences that inspire growth.

Here, you'll be encouraged to grow and progress in your own way, building connections with the people around you and sharing in our sense of belonging. Your life at AstraZeneca is defined by you and guided by us.

This job has expired.

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