Regulatory Affairs Strategy Director

About the role

AstraZeneca is seeking a passionate Regulatory Affairs Strategy Director to join our Cardiovascular, Renal or Metabolism (CVRM) regulatory affairs team. This role involves shaping global regulatory strategies and supporting the research, development, and commercialization of our products.

Responsibilities

• Provide strategic and operational regulatory leadership to the development, commercialization, and lifecycle management of assigned products.
• Serve as the global regulatory lead (GRL) on projects or specific indications of larger programs, or as the regional regulatory lead.
• Play a substantial role in crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.

Requirements

• Advanced Degree in Life Science or related discipline.
• 5+ years of proven experience defining and implementing the regulatory strategy for a pharmaceutical organization.
• Extensive knowledge of regulatory affairs within one or more therapeutic areas in early and late development.
• Proven track record of regulatory drug development including product approval/launch.
• Experience in leading major health authority interactions.
• Ability to think strategically and critically and evaluate risks to regulatory activities.
• Ability to work strategically within a complex, business-critical, and high-profile development program.

Qualifications

• Advanced Degree in Life Science or related discipline.
• 5+ years of proven experience defining and implementing the regulatory strategy for a pharmaceutical organization.
• Extensive knowledge of regulatory affairs within one or more therapeutic areas in early and late development.
• Proven track record of regulatory drug development including product approval/launch.
• Experience in leading major health authority interactions.
• Ability to think strategically and critically and evaluate risks to regulatory activities.
• Ability to work strategically within a complex, business-critical, and high-profile development program.

Skills

• Strategic thinking.
• Collaborative approach.
• Health Authority engagement.
• Complex project management.
• Regulatory compliance.

Benefits

Competitive salary and benefits package including a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles); benefits such as medical, prescription drug, dental, and vision coverage; and a qualified retirement program [401(k) plan].

Pay

The annual base salary for this position ranges from $186,232.80 - 279,349.20. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

Schedule

The annual base salary for this position ranges from $186,232.80 - 279,349.20. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.