ARTBIO

Compliance

• Serve as the point of contact for Health Authorities
• Translate program regulatory strategy into interaction plans, submission plans, timelines, and cross-functional deliverables for clinical-stage radiopharmaceutical programs
• Lead preparation, coordination, and delivery of regulatory submissions, including INDs, IND amendments, annual reports, meeting requests, CTAs, and other lifecycle submissions
• Schedule and coordinate meeting rehearsals before Health Authority interactions
• Finalize meeting minutes with Health Authorities, responses to information requests, and follow-up actions
• Oversee publishing and submissions
• Partner with Clinical, Medical, CMC, Quality, Nonclinical, Clinical Operations, and other contributors to develop content, resolve data gaps, and maintain an aligned submission narrative
• Maintain records of correspondence, commitments, decisions, and submission history
• Establish and maintain regulatory plans, workflows, submission calendars, trackers, and archives
• Coordinate regulatory medical writing across functions and translate research and development data and strategy into clear, compliant regulatory communications and high-quality submission deliverables

Explore Senior Director, Regulatory Affairs at ARTBIO. Review requirements and application details.