Regulatory Affairs Director - Oncology

AstraZeneca; Gaithersburg (MD); On-site; USD 186,000 - 279,000; Full time

Job summary

AstraZeneca seeks a Regulatory Affairs Director to shape US regulatory strategy for oncology therapies, accelerating innovation and patient access. You will lead regional regulatory initiatives across development, submission, approval and lifecycle management in a global matrix environment.

You will drive major submissions (INDs, NDAs, BLAs), engage health authorities, and guide cross-functional teams through complex programs with strategic insight and strong communication skills.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Significant regulatory affairs experience in pharma/biotech.
• Experience with regulatory strategies across development stages.
• Experience with INDs, NDAs and BLAs.
• Ability to lead cross-functional initiatives and influence stakeholders.
• Excellent communication and strategic thinking.
• Experience operating in a global matrix environment.

Responsibilities

• Develop regional regulatory strategies to support rapid approvals.
• Lead major regulatory submissions (INDs, NDAs, BLAs).
• Drive health authority engagement and interactions.
• Lead US Oncology Regulatory Strategy teams across functions.
• Assess regulatory risks and mitigation plans for programmes.
• Influence global product strategy with regulatory insight.
• Prepare regulatory strategy documents and briefing packages.
• Represent AstraZeneca in discussions with health authorities.

Skills

Strategic thinking

Leadership

Regulatory strategy

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences, Pharmacy, Biomedical Sciences or related

Advanced degree (MS, PharmD, PhD, MD or equivalent)

Job description

Do you want to shape the future of oncology medicines and influence regulatory decisions that impact patients globally?

At AstraZeneca, we are driven by our commitment to advancing science and delivering life-changing medicines. As a Regulatory Affairs Director, you will play a pivotal role in defining and executing US regulatory strategies that accelerate innovation and bring transformative oncology therapies to patients worldwide.

This is an opportunity to lead complex regulatory initiatives across development, submission, approval and lifecycle management activities while partnering with leading scientists, clinicians and commercial teams across a global matrix environment.

Why AstraZeneca?

At AstraZeneca, we follow the science and put patients first.

You will join a culture that values curiosity, courage and collaboration, where talented individuals are empowered to challenge convention and shape the future of healthcare. We invest in our people through meaningful career development, global mobility opportunities, leadership programmes and cutting-edge scientific innovation.

Our Oncology business continues to redefine what is possible in cancer treatment, creating opportunities for regulatory leaders to influence some of the most exciting programmes in the industry.

What You'll Do

As Regulatory Affairs Director, you will provide strategic and operational regulatory leadership for assigned development programmes and marketed products. You will serve as a Regional US Regulatory Lead for the Oncology programme.

Key Responsibilities Include

• Developing and implementing regional regulatory strategies that support rapid approvals and competitive product labelling.


• Leading major regulatory submissions, including INDs, NDAs and BLAs.


• Driving regulatory agency engagement strategies and leading health authority interactions.


• Leading cross-functional US Oncology Regulatory Strategy teams, clinical development, CMC, labelling and regional regulatory functions.


• Assessing regulatory risks and developing mitigation strategies to support programme success.


• Influencing global product strategy through regulatory expertise and scientific insight.


• Leading preparation of regulatory strategy documents, briefing packages and target labelling.


• Representing AstraZeneca in discussions with global health authorities and external stakeholders.

Essential Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biomedical Sciences or a related scientific discipline


• Significant experience within Regulatory Affairs, Regulatory Strategy and/or drug development in the pharmaceutical or biotechnology industry.


• Strong experience supporting regulatory strategies across early and late-stage development programmes.


• Experience with regulatory submissions and agency interactions, including INDs, NDAs and/or BLAs.


• Demonstrated ability to lead complex cross-functional initiatives and influence key stakeholders.


• Outstanding communication, strategic thinking and problem-solving skills.


• Experience operating effectively in a global matrix environment.

Preferred Qualifications

• Oncology regulatory experience.


• Advanced degree (MS, PharmD, PhD, MD or equivalent).


• Experience leading regulatory strategies through pivotal development milestones and health authority interactions.


• Prior involvement in regulatory approvals, response teams and labelling negotiations.

What Success Looks Like

In this role, you will:

• Deliver critical regulatory milestones for Oncology that support programme progression and approvals.


• Build productive relationships with health authorities and key internal stakeholders.


• Provide strategic leadership across complex, high-profile development programmes.


• Influence decisions that drive patient access to innovative medicines in the US market.

Compensation And Benefits

AstraZeneca is committed to providing competitive, equitable and transparent compensation.

The annual base pay for this position ranges from $186,232 - $279,349 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. 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 pay (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.

Inclusion & Diversity

AstraZeneca is an equal opportunity employer committed to fostering an inclusive and diverse workplace. We welcome applications from all qualified candidates and make employment decisions without regard to legally protected characteristics.

Date Posted

13-Oct-2026

Closing Date

15-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.