Regulatory Affairs Director - Oncology

AstraZeneca • Gaithersburg, MD

1d • Hybrid

About The Position

At AstraZeneca, the Regulatory Affairs Director (RAD) in Oncology Regulatory Science Strategy and Excellence (ORSSE) provides strategic and operational regulatory leadership for the development, commercialization, and life cycle management of assigned oncology products. This role serves as a global regulatory lead (GRL) for early-stage projects or specific indications, and/or as a regional regulatory lead. The RAD is instrumental in crafting and implementing clinical strategy and influencing health authorities to optimize outcomes, working to bring life-changing medicines to patients efficiently. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company dedicated to discovering, developing, and commercializing prescription medicines for serious diseases. The company fosters an inclusive and diverse environment, committed to lifelong learning, growth, and development, aiming to empower employees to push scientific boundaries and address global healthcare and sustainability challenges. AstraZeneca's mission is to create an inclusive and equitable environment where diversity drives innovation to deliver life-changing medicines.

Requirements

• Bachelor's degree in a science related field with at least 3 years of Regulatory strategy or related knowledge/experience.
• A solid knowledge of regulatory affairs within at least one therapeutic area in both 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.

Nice To Haves

• Advanced degree preferred.
• Experience in Oncology (small molecules & biologics) is 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.

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 that it is crafted to deliver rapid approval with competitive labeling 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, 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.
• Lead preparation of the regulatory strategy document and target product labeling.
• 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.

Benefits

• Competitive salary and benefits package
• Short-term incentive bonus opportunity
• Eligibility to participate in our equity-based long-term incentive program (salaried roles)
• Eligibility to receive a retirement contribution (hourly roles)
• Qualified retirement program [401(k) plan]
• Paid vacation
• Paid holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees