Regulatory Affairs Director – Radiopharma Strategy

ARTBIO, Inc.; Cambridge (MA); Hybride; USD 180 000 - 240 000; Plein temps

Résumé du poste

ARTBIO seeks a Senior Director, Regulatory Affairs to lead regulatory interactions and submission execution for our clinical-stage radiopharmaceutical programs. This role coordinates regulatory medical writing across functions to translate research data into compliant, high-quality submissions.

The position works cross-functionally with Clinical, CMC, Quality, and Operations to maintain an aligned submission narrative, and to ensure timely INDs, amendments, and lifecycle submissions.

Qualifications

• Bachelor’s degree in a scientific, medical, pharmacy, or related discipline.
• 12+ years of progressive regulatory affairs experience in biotech/pharma, with leadership in pre-IND to Phase 3 programs.
• Strong knowledge of US FDA requirements and interaction processes.
• Proven track record coordinating US INDs, amendments, annual reports, and FDA information requests.
• Experience with electronic submission publishing and external publishing vendors.

Responsabilités

• Lead regulatory interactions and submission execution for radiopharmaceutical programs.
• Coordinate regulatory medical writing across functions.
• Translate data and strategy into compliant regulatory communications for high-quality submissions.
• Prepare, coordinate, and deliver INDs, amendments, annual reports, meeting packages, CTAs, and lifecycle submissions.
• Maintain regulatory plans, calendars, trackers, and archives.

Connaissances

Regulatory leadership

US FDA knowledge

Regulatory strategy

Cross-functional collaboration

Regulatory writing

Project management

Formation

Bachelor’s degree in a scientific field

Advanced degree preferred

Outils

eCTD publishing

Document management systems

External publishers

Description du poste

ARTBIO seeks a Senior Director, Regulatory Affairs to lead regulatory interactions and submission execution for our clinical-stage radiopharmaceutical programs. This role coordinates regulatory medical writing across functions to translate research data into compliant, high-quality submissions.

The position works cross-functionally with Clinical, CMC, Quality, and Operations to maintain an aligned submission narrative, and to ensure timely INDs, amendments, and lifecycle submissions.