Regulatory Affairs Strategy Director

AstraZeneca • Gaithersburg, MD

1d • Hybrid

About The Position

The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned products. Serves as the global regulatory lead (GRL) on projects or specific indications of larger programs and/or as the regional regulatory lead. The RAD plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes. As a Regulatory Affairs professional within AstraZeneca, you will play a key role in channelling our scientific capabilities to make a positive impact on changing patients’ lives. In Regulatory Affairs, our teams influence the development of our innovative pipeline, define the regulatory strategy for our therapeutic assets, and engage with Health Authorities to effectively inform our development programs. In this way, our Regulatory Affairs teams are transforming exciting science into valued new medicines for patients around the world. Strategic thinking is key within our function. The more experienced you are, the more accountability you will have for strategic leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.

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.

Responsibilities

• Provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned products.
• Serves as the global regulatory lead (GRL) on projects or specific indications of larger programs and/or as the regional regulatory lead.
• Plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.
• Influence the development of our innovative pipeline.
• Define the regulatory strategy for our therapeutic assets.
• Engage with Health Authorities to effectively inform our development programs.
• Transforming exciting science into valued new medicines for patients around the world.
• Responsible for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.

Benefits

• Competitive salary and benefits package
• 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).
• Qualified retirement program [401(k) plan]
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director