Global Regulatory Strategy Lead - Oncology CGT

AstraZeneca GmbH; South San Francisco (CA); On-site; USD 218,000 - 327,000; Full time

Benefits offered by this job

Competitive salary and benefits

Office presence 3 days a week

Job summary

AstraZeneca seeks a Senior Director of Oncology CGT Regulatory Affairs to lead global regulatory strategy for high-complexity CGT programs, potentially serving as FRL/region RAD based on location. The role shapes strategy from early development through approvals, guiding cross-functional teams and engaging with global regulators.

Strong leadership, communication, and negotiation skills are required, with a track record in cell/gene therapy and oncology regulatory affairs.

Qualifications

• Advanced degree in a science-related field and 7–10 years of relevant experience.
• Demonstrated success in cell and/or gene therapy regulatory strategy.
• Deep understanding of global regulatory science and integration with program strategy.
• Experience with product development for multiple myeloma.
• Proven experience leading regulatory and cross-functional teams.

Responsibilities

• Lead development and implementation of global regulatory strategy for CGT products.
• Manage the Global Regulatory Strategy Team and mentor members.
• Oversee regulatory strategy for health authority meetings, BLA submissions, and expedited designations.
• Maintain knowledge of multiple myeloma and related regulatory considerations.
• Represent Regulatory Affairs on Global Product Teams and ensure on-time milestones.

Skills

Strategic leadership

Regulatory strategy

Stakeholder management

Cross-functional collaboration

Communication skills

Presentation skills

Education

Advanced degree in science-related field

Tools

FDA/EMA regulatory landscape

Job description

AstraZeneca seeks a Senior Director of Oncology CGT Regulatory Affairs to lead global regulatory strategy for high-complexity CGT programs, potentially serving as FRL/region RAD based on location. The role shapes strategy from early development through approvals, guiding cross-functional teams and engaging with global regulators.

Strong leadership, communication, and negotiation skills are required, with a track record in cell/gene therapy and oncology regulatory affairs.