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Global Regulatory Affairs DirectorAstraZeneca · US - Gaithersburg - MD
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AstraZeneca

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Global Regulatory Affairs Director

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🗓️ Posted 2026-09-17 US - Gaithersburg - MD Full-time Hybrid Healthcare Medical
💰 Salary Not shared 📊 Market 15,000 GBP–25,000 GBP/mo

About the Company

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 effe

Requirements

  • ● Bachelor's Degree in Life Science or related discipline,
  • ● Advanced degree a plus.
  • ● 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/astrazenecacareers/ 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.
  • ● AstraZeneca is 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 emailing [email protected] .
  • ● 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.