Global Regulatory Strategy Director

AstraZeneca; Cambridge (MA); On-site; USD 186,000 - 279,000; Full time

Benefits offered by this job

Short-term incentive bonuses

Equity-based awards

Retirement programs

Paid time off

Health, dental, and vision coverage

Job summary

AstraZeneca seeks a seasoned Regulatory Leader to guide strategic regulatory activities across development, launch, and lifecycle for assigned products. You will influence authorities and collaborate with global teams to shape regulatory strategies and compliance.

With 6+ years in regulatory affairs, you will oversee risk assessments, provide coaching, and ensure timely submissions while aligning with global standards and local regulations.

Qualifications

• Bachelor’s Degree in Life Science or related discipline.
• 6 years experience in regulatory drug development, manufacture, commercialization or equivalent.
• Proven leadership and project management experience.
• Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and licence maintenance.

Responsibilities

• Provide strategic and operational regulatory leadership to development, commercialization and lifecycle management of assigned products.
• Apply knowledge of local and global regulatory trends to identify future regulatory requirements and strategies.
• Influence Regulatory authorities through regular contacts to improve regulatory outcomes.
• Contribute effectively to Global Development programmes, providing expert advice and interpretive inputs on market legislation and requirements that impact registrations.

Skills

Regulatory leadership

Project management

Cross-functional collaboration

Regulatory procedures knowledge

Education

Bachelor’s Degree in Life Science

Advanced degree (MS, PharmD or PhD) a plus

Job description

AstraZeneca seeks a seasoned Regulatory Leader to guide strategic regulatory activities across development, launch, and lifecycle for assigned products. You will influence authorities and collaborate with global teams to shape regulatory strategies and compliance.

With 6+ years in regulatory affairs, you will oversee risk assessments, provide coaching, and ensure timely submissions while aligning with global standards and local regulations.