Regulatory Strategy Director – Cell Therapies

AstraZeneca GmbH; Cambridge (MA); On-site; USD 136,000 - 203,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation and holidays

Health benefits

Job summary

AstraZeneca is seeking an Associate Regulatory Affairs Director (ARAD) in the United States to lead regulatory strategy for advanced cell therapies. You will partner with the Global Regulatory Strategy Team to plan and execute submissions, while managing risks and optimizing interactions with health authorities across regions.

The role emphasizes strong project leadership, regulatory knowledge, and the ability to drive high-quality submissions.

Qualifications

• Bachelor's degree in a scientific discipline, Regulatory Sciences, Pharmacy, or related field.
• Master’s, PharmD, or PhD in Science or Regulatory field preferred.
• 7+ years regulatory experience in biopharma or health authority.

Responsibilities

• Partner with global regulatory team to define stage-appropriate regulatory strategy across regions.
• Monitor evolving global/regional guidelines to support development plans.
• Lead and contribute to regulatory submissions (IND, CTA, BLA, IVDR) for cell therapies.
• Advise teams on opportunities to accelerate development and address regulatory hurdles.
• Engage with health authorities to inform submission delivery strategies and timelines.
• Develop submission delivery plans and provide status updates to stakeholders.
• Support operational/compliance activities for projects.
• May handle routine/non-routine health authority communications.
• Provide coaching and knowledge sharing within Regulatory Affairs.
• Contribute to governance meetings and process improvements.

Skills

Excellent written and verbal comms

Cultural awareness

Scientific regulatory knowledge

Project management

Independent & team work

Influencing & stakeholder mgmt

Problem analysis & actions

Continuous improvement

Education

Bachelor's degree in science/regulatory field

Master’s/PhD in related discipline

Tools

Artificial intelligence tools

Job description

AstraZeneca is seeking an Associate Regulatory Affairs Director (ARAD) in the United States to lead regulatory strategy for advanced cell therapies. You will partner with the Global Regulatory Strategy Team to plan and execute submissions, while managing risks and optimizing interactions with health authorities across regions.

The role emphasizes strong project leadership, regulatory knowledge, and the ability to drive high-quality submissions.