Regulatory Affairs Director at AstraZeneca in Gaithersburg, MD

Regulatory Affairs Director
Location: US - Gaithersburg - MD
The Infectious Disease Unit at AstraZeneca is constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We are utilizing our expertise in virology, microbiology and vaccines to enable novel approaches to prevent and treat infectious diseases. Within ID Regulatory Affairs, we take innovative regulatory approaches and work across our pipeline and the business to deliver medicines to patients as efficiently and effectively as possible.

The Regulatory Affairs Director (RAD) is responsible for providing strategic regulatory leadership to the development, commercialization and life cycle management of assigned product(s). The RAD applies knowledge of current local and global regulatory trends to identify future regulatory requirements and strategies and influences regulatory authorities through regular contacts to improve regulatory outcomes.

Accountabilities
Develop and implement the regional or global regulatory strategy, ensuring it is crafted to deliver rapid approval with competitive labelling that is identified by the business, markets and patients
Lead the development of the global regulatory strategy document for assigned product(s) and the planning and construction of the global dossier and core prescribing information
Lead cross functional teams in major regulatory submissions (BLA/MAA/IND/CTA), health authority interactions, label discussions, and securing approvals
Deliver regulatory milestones for assigned project(s), including the assessment of risks and mitigations, emerging data and the probability of regulatory success
Ensure effective collaboration across global, regional and local Regulatory Affairs, enabling rapid and effective submissions, approvals and other product maintenance activities
Participate in skill-development, coaching and performance feedback of other regulatory staff working on the product/project

Minimum Qualifications:
Bachelor’s Degree in a life science or related field.
7+ years of experience in regulatory drug development, manufacture, commercialization or equivalent
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, marketing approvals, line extensions and license maintenance
Proven successful leadership and project management experience
Excellent oral, written, and presentation skills
Ability to work in a fast-paced environment in a hands-on fashion

Desirable Qualifications:
Advanced degree in science related field and/or other appropriate knowledge/experience
Previous experience in vaccines or anti-infective therapies
Ability to work strategically in a global regulatory lead role on business-critical and high-profile development programs
Experience supporting a global regulatory approval or major submission activity
Experience with FDA advisory committee or EMA oral explanation preparation
Experience working on due diligence activities or in a business alliance environment

Why AstraZeneca
Here, regulatory leaders help transform pioneering science into therapies that reach patients faster—by driving innovative approaches, smart risk-taking, and disciplined execution. You will work across a rich pipeline with colleagues who value curiosity and kindness alongside ambition, bringing unexpected teams together to unlock knowledge and sharpen strategy.

Our globally connected community blends cutting-edge technology with deep disease expertise, embraces data and automation to reduce cycle times, and thrives on collaboration that turns complex challenges into concrete outcomes for patients. Your ideas will be heard, your growth supported, and your impact visible in every milestone we achieve.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions.

That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible.

We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base pay for this position ranges from $186,232 - $279,349 USD Annual. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted
28-Sep-2026
Closing Date
12-Oct-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.