Senior Regulatory Affairs Director- Infectious Diseases

AstraZeneca • Gaithersburg, MD

3d • Hybrid

About The Position

AstraZeneca is committed to developing and delivering transformative vaccines and antibodies and advancing infectious disease therapies to improve public health. The Senior Regulatory Affairs Director (SRAD) leads global regulatory strategy for complex products, aiming to secure rapid approval that meets business, market, and patient needs. The role provides strategic leadership and expertise in global regulatory science, drug development, and regulatory strategies for high-profile programs. Disease-area familiarity is essential for influencing cross-functional discussions with Global Product Teams and other stakeholders.

The SRAD may serve as Global Regulatory Lead for a product group and may also act as a regional lead depending on location. The role requires strategic leadership and an understanding of global regulatory science from early- and late-stage development through commercialization strategy, as well as engagement with Global Health Authorities. The position works across a globally connected pipeline and collaborates with colleagues using technology, data, and automation to support regulatory efficiency. AstraZeneca expects an average minimum of three days per week in the office, with flexibility.

Requirements

• Master’s degree in a science-related field.
• At least 10 years of experience, or equivalent, in regulatory drug development.
• Successful contribution to a major regulatory approval at a global level.
• Previous experience leading major Health Authority interactions, such as FDA advisory committee meetings, oral explanations, Scientific Advice, Pre-NDA/BLA, or EOP2 meetings.
• Proven leadership and program management experience.
• Ability to think strategically and critically evaluate risks to regulatory activities.
• Ability to work strategically within a complex, business-critical, high-profile development program.

Nice To Haves

• An advanced degree.
• Experience in Infectious Diseases.

Responsibilities

• Lead or deputise for the Therapeutic Area or Regional Vice President in senior-level internal and external interactions, including contributions to internal governance.
• Develop and implement product regulatory strategies to secure rapid approval with advantageous labeling.
• Lead the planning and construction of global dossiers and core prescribing information.
• Conduct regulatory risk planning and mitigation.
• Serve as the single point of contact and Global Regulatory Affairs representative on Product Development Teams.
• Lead the Global Regulatory Sub-team, incorporating regional regulatory needs into the Global Regulatory Strategy and ensuring execution.
• Deliver regulatory milestones, assess probabilities of regulatory success, and implement risk mitigation measures.
• Partner with marketing and regional regulatory affairs staff to shape the environment and Health Authorities’ views on relevant topics.
• Lead regulatory staff on complex projects to deliver prioritized objectives on time and with quality.
• Ensure effective regulatory representation at Health Authority meetings and clearly document discussions.
• Lead development and updates of the Regulatory Strategy Document for complex projects.
• Monitor regulatory-environment changes and advise Global Product Teams accordingly.
• Provide regulatory leadership in product in-license and due diligence reviews, divestment, and withdrawal.
• Lead complex cross-functional projects designed to improve efficiency and simplify processes.

Benefits

• Qualified retirement program, including a 401(k) plan.
• Paid vacation and holidays.
• Paid leaves.
• Medical, prescription drug, dental, and vision coverage.
• Short-term incentive bonus opportunity.
• Eligibility to participate in an equity-based long-term incentive program for salaried roles.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior