Global Regulatory Affairs Director – Late R&I
Location: Gaithersburg, Maryland, United States
Job ID: R-238665
Date Posted: 06/11/2025
Closing Date: 04/12/2025
Role Overview
AstraZeneca is seeking a Global Regulatory Affairs Director – Late Respiratory & Immunology (R&I) to provide strategic and operational regulatory leadership across the development, commercialization, and lifecycle management of assigned products. This role supports AstraZeneca’s growing pipeline in Respiratory & Immunology (R&I) and Cardiovascular, Renal & Metabolism (CVRM).
The position requires strong regulatory expertise, cross-functional collaboration, and the ability to influence regulatory authorities to achieve optimal regulatory outcomes.
Key Responsibilities
1. Regulatory Strategy & Leadership
Provide strategic regulatory leadership for product development, registration, and lifecycle management.
Monitor and interpret regulatory changes in assigned regions and integrate them into regulatory plans.
Ensure inclusion of robust risk assessments and mitigation plans in regulatory strategies.
2. External Representation & Influence
Lead lobbying and influence efforts with regulatory agencies and trade associations.
Represent AstraZeneca on Trade Association committees to communicate AZRA/AZ positions on regulatory issues.
Maintain regular interaction with regulatory authorities to strengthen regulatory outcomes.
3. Cross-Functional Collaboration
Provide expert input to Global Development programs, ensuring compliance with market legislation.
Collaborate across global, regional, and local Regulatory Affairs teams to enable fast and efficient submissions, approvals, and maintenance activities.
4. Compliance & Quality Oversight
Ensure all markets maintain compliance with product licenses and regulatory requirements.
Support development and training of regulatory personnel to ensure understanding of quality and compliance standards.
5. Talent Development
Participate in coaching, skill development, and performance feedback for regulatory staff working on assigned products.
Foster a culture of courageous leadership, creativity, collaboration, and continuous improvement.
Essential Qualifications
Bachelor’s Degree in Life Sciences or related discipline (advanced degree preferred).
Minimum 6 years regulatory experience in the pharmaceutical industry.
Strong experience in regulatory drug development, manufacturing, commercialization, or equivalent.
Proven project leadership and regulatory strategy experience.
Background in multiple regulatory groups or experience working in a health authority.
Strong knowledge of global regulatory legislation for drug development, product registration, line extensions, and license maintenance.
Desirable Qualifications
Extensive experience across global regulatory projects and regions.
Strong commercial awareness.
Excellent problem-solving skills.
Strong negotiation and strategic influencing skills.
Ability to build collaborative working relationships.
Focused on delivery and achieving results.
Work Model
Flexible hybrid model.
Expected 3 days/week onsite to promote collaboration and teamwork.
Compensation & Benefits
Annual Base Salary: $186,232 – $279,349
(Actual pay may vary based on experience, skills, and location.)
Eligible for:
Short-term incentive bonus
Equity-based awards (for salaried roles)
Retirement program (401k)
Paid time off (vacation, holidays, leaves)
Health, dental, and vision insurance
Why AstraZeneca?
AstraZeneca fosters an environment that encourages innovation, teamwork, and lifelong learning. Employees are empowered to push scientific boundaries and drive meaningful impact for patients worldwide. The culture values:
Collaboration
Diversity and inclusion
Entrepreneurial thinking
Continuous development
Equal Opportunity
AstraZeneca welcomes applicants from diverse backgrounds. Applicants with disabilities may request reasonable accommodation during the hiring process.
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