Global Regulatory Strategy Lead

ARTBIO; United States; Remote; USD 250,000 - 380,000; Full time

Benefits offered by this job

First-in-class cancer therapies

Radiochemistry & CMC exposure

Hands-on training

International collaboration culture

Competitive compensation

Job summary

ARTBIO seeks a Head of Regulatory Affairs to lead the regulatory function for clinical-stage radiopharmaceutical programs. This leadership role requires deep expertise in global regulatory strategy, submissions (INDs, NDAs, BLAs, MAAs), and engagement with health authorities worldwide to ensure compliant execution across the drug development lifecycle.

The ideal candidate will drive risk identification, cross-functional collaboration, and build regulatory capability with a focus on

Qualifications

• Advanced degree in a scientific discipline is preferred.
• 15+ years of regulatory affairs experience in biotech/pharma, with emphasis on drug development.
• In-depth knowledge of global regulatory requirements and guidelines (FDA, EMA, etc.).
• Proven track record of successful regulatory submissions (INDs, NDAs, BLAs, MAAs).
• Experience leading strategies for complex programs across multiple therapeutic areas.

Responsibilities

• Define and lead global regulatory strategy for clinical-stage radiopharmaceutical programs.
• Lead regulatory submissions, including INDs, CTAs, and DMFs.
• Lead FDA and global health authority interactions, including meeting prep and responses.
• Ensure compliance across the drug development lifecycle (clinical trials and manufacturing).
• Identify regulatory risks and develop mitigation strategies.
• Advise executive leadership on timelines and decision points.

Skills

Regulatory leadership

IND/NDAs/MAAs submissions

FDA/EMA interactions

Regulatory strategy

Education

Advanced degree (JD/PhD/PharmD/MD)

Job description

ARTBIO seeks a Head of Regulatory Affairs to lead the regulatory function for clinical-stage radiopharmaceutical programs. This leadership role requires deep expertise in global regulatory strategy, submissions (INDs, NDAs, BLAs, MAAs), and engagement with health authorities worldwide to ensure compliant execution across the drug development lifecycle.

The ideal candidate will drive risk identification, cross-functional collaboration, and build regulatory capability with a focus on