Global Oncology Regulatory Director: Strategy & Approvals

AstraZeneca GmbH; Gaithersburg (MD); On-site; USD 178,534 - 267,801; Full time

Benefits offered by this job

401(k) plan

Health benefits

Paid vacation

Job summary

AstraZeneca seeks a Regulatory Affairs Director - Oncology to lead global regulatory strategy and submissions from Gaithersburg, MD. You will drive cross-functional teams, shape engagement with health authorities, and influence labeling across markets to accelerate patient access.

You will mentor a Global Regulatory Strategy Team, craft strategic documents, and own milestones to ensure robust, compliant approvals in a fast-paced, science-driven environment.

Qualifications

• Bachelor's degree in a science-related field with at least 3 years of Regulatory strategy experience.
• Solid knowledge of regulatory affairs within oncology in early and late development.
• Experience in regulatory drug development and major HA interactions.
• Strategic thinking, influencing, risk evaluation, initiative and leadership with strong communication.

Responsibilities

• Lead cross-functional teams in major regulatory submissions (NDA/BLA/IND/CTA) and health authority interactions.
• Develop regional/global strategy to deliver rapid approvals with competitive labeling identified by markets.
• Craft health authority engagement strategy and briefing documents; lead rehearsals and meetings.
• Lead a Global Regulatory Strategy Team (GRST) and mentor its members.
• Deliver regulatory milestones with risk mitigations and labeling plans.
• Own negotiations with health authorities and key regulatory documents.
• Plan and construct the global dossier and core prescribing information.
• Partner with marketing and regional staff to influence guidance.

Skills

Strategic thinking

Cross-functional leadership

Regulatory strategy

Excellent communication

Education

Bachelor's degree in science

Job description

AstraZeneca seeks a Regulatory Affairs Director - Oncology to lead global regulatory strategy and submissions from Gaithersburg, MD. You will drive cross-functional teams, shape engagement with health authorities, and influence labeling across markets to accelerate patient access.

You will mentor a Global Regulatory Strategy Team, craft strategic documents, and own milestones to ensure robust, compliant approvals in a fast-paced, science-driven environment.