Regulatory Affairs Director - Oncology

Oncology Regulatory Science and Strategy

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 Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products. Serves as the global regulatory lead (GRL) on early stage projects or specific indications of larger programs and/or as the regional regulatory lead. The RAD plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.

What you’ll do

• Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.
• Develop and implement the program's regional or global strategy ensuring that it is crafted to deliver rapid approval with driven labelling that is identified by the business, markets and patients.
• Craft the health authority engagement strategy and interaction plan, drive the formulation of the briefing document focused on strategy and scientific content, lead the team through meeting rehearsals and moderate the meeting itself.
• Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labelling and members of the submission and execution team. Mentor and provide performance feedback to members of your GRST.
• Deliver regulatory landmarks on your team including an assessment of risks and mitigations, emerging data, and the probability of success. Lead preparation of the regulatory strategy document and target product labelling.
• Own the negotiations with health authorities and initiate and deliver key regulatory documents.
• Plan and construct the global dossier and core prescribing information including product maintenance, supply and compliance activities.
• Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.

Education, Qualifications, Skills and Experience

Essential for the role:

• An advanced degree in a science related field and/or other appropriate knowledge/experience

• A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development
• Previous experience of regulatory drug development or equivalent, and experience with major HA interactions.
• Demonstrated competencies of critical thinking, strategic influencing, risk evaluation, innovation, initiative, leadership and excellent oral and written communication skills.
• The ability to think strategically and critically and evaluate risks to regulatory activities.

Desirable for the role:

• Experience in Oncology (small molecules & biologics)
• Prior experience with phase 3 design including end of phase 2 health authority interactions
• Contribution to a regulatory approval including leading response team and labelling negotiations
• Knowledge and understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design
• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs
• Ability to work strategically within a business critical and high-profile development program
• Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component.

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.