Regulatory Affairs Director

About the role

The Regulatory Affairs Director (RAD) at AstraZeneca will provide strategic and operational regulatory leadership for oncology products. This role involves leading cross-functional teams in major regulatory submissions, health authority interactions, label discussions, and securing approvals. The RAD also crafts and implements the program's strategy, drives health authority engagement, and leads the Global Regulatory Strategy Team.

Responsibilities

• 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 it delivers rapid approval with competitive labeling.
• 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, Labeling, and members of the submission and execution team. Mentor and provide performance feedback to members of your GRST.
• Deliver regulatory milestones on your team including an assessment of risks and mitigations, emerging data, and the probability of success.
• 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.

Requirements

• Bachelor's degree in a science related field with at least 3 years of Regulatory strategy or related knowledge/experience.
• Solid knowledge of regulatory affairs within oncology area in early and late development.
• Previous demonstrated experience of regulatory drug development or equivalent, and experience with major HA interactions.
• Demonstrated competencies of strategic thinking, strategic influencing, risk evaluation, innovation, initiative, leadership, and excellent oral and written communication skills.

Preferred Qualifications

• Advanced degree preferred.
• Prior experience with phase 3 design including end of phase 2 health authority interactions.
• Contribution to a regulatory approval including leading response team and labeling 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.

Benefits

Competitive Salary and Benefits Package including a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered include a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.