Regulatory Affairs Strategy Director
$186k/y-$279k/y
AstraZeneca2 days ago
Highlight
OnsiteFull-timeSenior
Summary
AstraZeneca is seeking a Regulatory Affairs Strategy Director to join their team in Gaithersburg, MD. The role involves providing strategic and operational regulatory leadership for the development, commercialization, and life cycle management of assigned products.
About the Role
As a Regulatory Affairs Strategy Director, you will be responsible for defining and implementing global regulatory strategies, engaging with health authorities, and influencing the development of innovative medicines. You will lead major health authority interactions and ensure compliance with regulatory requirements while working collaboratively across disciplines.
About You
Required:
- 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.
Benefits
- Competitive salary ranging from $186k–$279k.
- Short-term incentive bonus opportunity.
- Eligibility to participate in equity-based long-term incentive program.
- 401(k) retirement plan.
- Paid vacation and holidays.
- Health benefits including medical, prescription drug, dental, and vision coverage.
AstraZeneca
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio
Gaithersburg, MD