Regulatory Affairs Director

AstraZeneca • Gaithersburg, MD

20h • Hybrid

About The Position

At AstraZeneca, we follow the science and turn ideas into life changing medicines with the upmost integrity. We continuously forge partnerships that help bring world-class treatments to patients in new ways. Within Oncology Regulatory Science Strategy and Excellence (ORSSE), the mission is to bring hope and solutions to patients with unmet needs by working across the pipeline and business to get medicines to patients as efficiently and optimally 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. This role 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. The position is based in Gaithersburg, MD, one of over 400 AstraZeneca sites, which provides a collaborative and vibrant environment. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company dedicated to discovering, developing and commercialising prescription medicines for serious diseases. The company is committed to building an inclusive and diverse team, embracing diversity and equality of opportunity, and fostering a culture of collaboration and teamwork. AstraZeneca aims to be a Great Place to Work, empowering employees to push boundaries, challenge convention, and drive change to meet global healthcare and sustainability challenges. The company emphasizes lifelong learning, growth, and development, and an inclusive and equitable environment where people belong, leveraging diversity for innovation in science and medicine.

Requirements

• Bachelor's degree in a science related field
• 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 on offer
• individualized flexibility
• qualified retirement program [401(k) plan]
• paid vacation
• paid holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage
• short-term incentive bonus opportunity
• eligibility to participate in our equity-based long-term incentive program (salaried roles)
• to receive a retirement contribution (hourly roles)

What This Job Offers

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