Job Title: Global Regulatory Affairs Director
Location: Gaithersburg

Introduction to Role:

Provides strategic and operational regulatory leadership to the development, commercialisation and life cycle management

of the assigned product(s) in product teams. Applies knowledge of current local and global Regulatory trends to identify

future regulatory requirements and strategies. Influences Regulatory authorities through regular contacts to improve

Regulatory outcomes.

Responsible for the management of a skill group such as CMC, Regulatory affairs project management, etc. Responsible for

skill development, performance management, resource allocation.

Accountabilities:
• Provides effective lobbying and influencing on regulatory agencies and trade associations on product and legislative

development issues and monitors changes in the regulatory environment in nominated region to support and advise

relevant functions
• Provides strategic regulatory advice support for product developments regional therapy area
• Represents AZRA on relevant external Trade Association committees to ensure AZRA and/or AZ views on key issues are

known
• Ensures adequate risk assessments and mitigation plans are included in the regulatory strategy documents
• Contribute effectively to Global Development programmes, providing expert advice and interpretive inputs on market

legislation and requirements that impact on new and existing product registrations
• Ensures effective collaboration across the global, regional and local Regulatory Affairs interface enabling rapid and

effective submissions, approvals and other product maintenance activities
• Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the

product/project
• Ensures all markets remain in compliance with product licences maintained and ensuring improvement plans are in

place to close compliance gaps. Provide support and advice on training and development to ensure all regulatory

personnel in markets have an appropriate knowledge of quality and compliance
• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration

Essential Skills/Experience:

• Bachelor's Degree in Life Science or related discipline,
• Advanced degree a plus.
• 6 years experience of regulatory drug development,
• Manufacture, commercialisation or equivalent.
• Proven successful leadership and project management experience
• Broad background of experience of working in several groups in regulatory affairs or experience at a health authority.
• Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and licence maintenance

Where can I find out more?

• Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
• Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
• Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
• Our US Footprint: Powering Scientific Innovation - YouTube

The annual base pay (or hourly rate of compensation) for this position ranges from $186,232 to $279,349. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

#LI-Hybrid

Date Posted
16-Sept-2026

Closing Date
24-Sept-2026