Global Regulatory Affairs Director

AstraZeneca GmbH; Gaithersburg (MD); On-site; USD 186,000 - 279,000; Full time

Benefits offered by this job

Retirement plans

Paid time off

Health/dental/vision coverage

Job summary

AstraZeneca in Gaithersburg is seeking a Global Regulatory Affairs Director to provide strategic regulatory leadership across development, commercialization, and lifecycle management. You will apply global regulatory trends to shape strategies and influence authorities to improve outcomes.

The role requires leadership, strong project management, and a broad regulatory background, including health authority interactions, with a focus on collaboration across global teams and regions.

Qualifications

• Bachelor’s degree or higher in life sciences or related field.
• Advanced degree is a plus.
• 6 years of regulatory drug development experience.
• Broad regulatory affairs background including health authority interactions.
• Proven leadership and project management experience.

Responsibilities

• Provide strategic and operational regulatory leadership for development, commercialization and lifecycle management of assigned products.
• Apply knowledge of local and global regulatory trends to identify future requirements and strategies.
• Influence regulatory authorities through regular contacts to improve outcomes.
• Manage skill groups, develop talent, and allocate resources.
• Collaborate across global, regional, and local Regulatory Affairs interfaces for submissions and maintenance.

Skills

Regulatory leadership

Project management

Regulatory affairs knowledge

Leadership experience

Regulatory strategy

Education

Bachelor’s Degree in Life Science or related discipline

Advanced degree

Job description

Job Title: Global Regulatory Affairs Director Location: Gaithersburg

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

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.

AstraZenecais an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by [e-mail].

#LI-Hybrid

Date Posted

16-Sept-2026

Closing Date

24-Sept-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.