Executive Regulatory Leader — Respiratory & Immunology

AstraZeneca GmbH; Gaithersburg (MD); Hybrid; USD 240,000 - 400,000; Full time

Benefits offered by this job

401(k) retirement plan

Vacation and holidays

Paid leaves

Health benefits

Job summary

AstraZeneca GmbH in the United States is seeking an Executive Regulatory Science Director, Respiratory & Immunology, to provide global regulatory expertise and oversight across discovery, development and commercialization.

You will lead regulatory strategy, manage senior stakeholder interactions with health authorities, mentor RADs, and drive submissions for respiratory and immunology programs, while navigating ambiguity.

Qualifications

• Bachelor's degree in life sciences or related field.
• 10+ years drug development experience.
• Experience leading regulatory strategy and submissions.
• Significant experience inHealth Authority interactions (e.g., FDA, EMA).
• Experience managing teams in a matrixed organization.

Responsibilities

• Provide oversight and mentor RADs and SrRADs to craft regulatory strategies.
• Lead discussions with global health authorities to enable rapid approvals and strategic labelling.
• Influence regulatory strategies across early to post-marketing stages for respiratory and immunology.
• Represent Regulatory function in senior governance and cross-functional forums.
• Collaborate with regional groups to assess emerging science and regulatory changes.

Skills

Regulatory strategy

Global regulatory submissions

Stakeholder leadership

Health Authority interactions

Team leadership

Education

Bachelor's degree in life sciences

Advanced degree preferred (MS/PhD/PharmD/MD)

Job description

AstraZeneca GmbH in the United States is seeking an Executive Regulatory Science Director, Respiratory & Immunology, to provide global regulatory expertise and oversight across discovery, development and commercialization.

You will lead regulatory strategy, manage senior stakeholder interactions with health authorities, mentor RADs, and drive submissions for respiratory and immunology programs, while navigating ambiguity.