Executive Regulatory Science Director, Respiratory & Immunology

About the role

Join us at AstraZeneca, where we are investing in internal capabilities to discover and accelerate the delivery of next-generation respiratory and immunology modalities for patients. As part of our Regulatory Affairs team, you will play a crucial role in bringing these transformative therapies from the lab to life.

This role requires comfort interacting with senior leaders, strong negotiation skills, decisiveness in ambiguity, and the ability to provide global strategic regulatory expertise and oversight to support products through research, development, and commercialization. Expertise applies to early, late, and post-marketing development stages for respiratory and immunology diseases. You will ensure adequate regulatory resources and skills align with disease area strategies and portfolio goals to enhance success for business needs, health authorities, and patients. Partnering with functions, you will assign regulatory experts to provide strategic advice at key milestone investment decisions across the portfolio.

Responsibilities

• Provide oversight, partner with, and mentor Regulatory Affairs Directors (RADs) and Senior RADs to develop strategies for products or product groups consistent with disease area and portfolio strategy.
• Craft and negotiate strategies with global health authorities (e.g., FDA, EMA, CDE) to deliver rapid approval with competitive labeling aligned with product properties and business/patient needs.
• Lead discussions in internal and external forums, offering expertise in regulatory knowledge of disease areas.
• Influence and drive regulatory strategies and recommendations at all development stages, including early/late development and established brands, for respiratory and immunology therapies, as well as novel tools like endpoints, biomarkers, study designs, and digital applications.
• Represent the Regulatory function in senior-level interactions at internal governance technical review committees (e.g., Development Review Committee, Early Development Review Board, Global Medical Affairs Review Committees).
• Collaborate with regional policy and intelligence groups to critically analyze emerging science, data, and changes in the regulatory environment.
• Define and drive global regulatory policies and priorities within the therapeutic area.

Requirements

• Bachelor’s degree in life sciences, a science-related field, or equivalent knowledge/experience.
• More than 10 years of drug development experience.
• Broad experience in the therapeutic area (respiratory/immunology expertise is a plus).
• Experience in global regulatory strategy and submissions that have progressed to registration.
• Significant experience leading major Health Authority interactions.
• Broad background in the pharmaceutical/medical industry, with experience in multiple areas of regulatory affairs (e.g., Global, European, International, Marketing Company) or prior experience at a health authority.
• Experience managing people in a matrixed organizational structure.

Preferred Qualifications

• Advanced degree in a scientific field (e.g., MSc, PhD, PharmD, MD).

Schedule

In-person working gives us the platform to connect, work at pace, and challenge perceptions. We work, on average, a minimum of three days per week from the office while respecting individual flexibility.

Pay

The annual base salary for this position in the US ranges from $266,596.80 to $399,895.20. Base pay may vary depending on market location, job-related knowledge, skills, and experience. In addition, this role offers a short-term incentive bonus opportunity and eligibility to participate in our equity-based long-term incentive program (for salaried roles) or receive a retirement contribution (for hourly roles).

Benefits

• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Health benefits, including medical, prescription drug, dental, and vision coverage.