Global Regulatory Strategy Director

AstraZeneca plc; Cambridge (MA); Hybrid; USD 186,000 - 279,000; Full time

Job summary

AstraZeneca plc in Cambridge, MA, invites you to shape regulatory strategy across development, commercialization and life cycle management. You will lead regulatory planning, coordinate with product teams, and influence authorities to secure timely approvals while ensuring compliance.

The role emphasizes collaboration across global, regional, and local regulatory affairs, coaching staff, and staying ahead of evolving laws.

Qualifications

• Bachelor’s Degree in Life Science or related discipline.
• Advanced degree (MS, PharmD or PhD) a plus.
• 6 years experience of regulatory drug development, manufacture, commercialization 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.

Responsibilities

• Provide strategic and operational regulatory leadership to the development, commercialization and life cycle management of the assigned products in product teams.
• Apply knowledge of current local and global Regulatory trends to identify future regulatory requirements and strategies.
• Influence Regulatory authorities through regular contacts to improve regulatory outcomes.
• Ensure effective collaboration across the global, regional and local Regulatory Affairs interface enabling rapid and effective submissions, approvals and other product maintenance activities.
• 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.
• Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project.

Skills

Regulatory leadership

Project management

Cross-functional collaboration

Regulatory strategy

Education

Bachelor’s Degree in Life Science or related discipline

Advanced degree (MS, PharmD or PhD)

Job description

AstraZeneca plc in Cambridge, MA, invites you to shape regulatory strategy across development, commercialization and life cycle management. You will lead regulatory planning, coordinate with product teams, and influence authorities to secure timely approvals while ensuring compliance.

The role emphasizes collaboration across global, regional, and local regulatory affairs, coaching staff, and staying ahead of evolving laws.