Regulatory Strategy Director — Radiopharmaceuticals

Artbio; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive compensation and benefits

Hands-on training and development

International, collaborative culture

Exposure to radiochemistry and CMC

Job summary

ARTBIO, a pioneering biotech company, seeks a Senior Director of Regulatory Affairs to lead regulatory interactions for clinical-stage radiopharmaceutical programs. You will coordinate medical writing, ensure compliant submissions, and partner with Clinical, Medical, CMC, Quality, and other teams to craft a cohesive regulatory narrative.

You will drive INDs, annual reports, and lifecycle submissions, while establishing submission plans, timelines, and archives.

Qualifications

• Bachelor’s degree in a scientific, medical, pharmacy, or related discipline is required; advanced degree preferred.
• 12+ years of progressive regulatory affairs experience in biotech/pharma with leadership in pre-IND to Phase 3 oncology programs.
• Strong knowledge of US FDA requirements and interaction processes.
• Experience leading US INDs, amendments, annual reports, and responses to FDA information requests.

Responsibilities

• Serves as the point of contact for Health Authorities.
• Translates regulatory strategy into interaction and submission plans, timelines, and cross-functional deliverables.
• Leads preparation, coordination, and delivery of regulatory submissions including INDs and annual reports.
• Schedules and coordinates meeting rehearsals before Health Authority interactions.
• Finalizes meeting minutes, responses, and follow-up actions.
• Maintains regulatory plans, calendars, trackers, and archives.

Skills

Regulatory leadership

US FDA regulations

IND submissions

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's degree in a scientific/medical discipline

Advanced degree preferred

Tools

eCTD publishing

Document management

External publishing vendors

Job description

ARTBIO, a pioneering biotech company, seeks a Senior Director of Regulatory Affairs to lead regulatory interactions for clinical-stage radiopharmaceutical programs. You will coordinate medical writing, ensure compliant submissions, and partner with Clinical, Medical, CMC, Quality, and other teams to craft a cohesive regulatory narrative.

You will drive INDs, annual reports, and lifecycle submissions, while establishing submission plans, timelines, and archives.