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.

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 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.

Preferred:

• 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.

Location: Cambridge, UK or Gaithersburg, US

Closing Date: 15th November 2020

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

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.