Learn about how ARTBIO is redefining cancer care through a new class of alpha radioligand therapies and building an ecosystem to maximize their potential. Backed by Third Rock Ventures.
About the role
The Senior Director, Regulatory Affairs leads and coordinates regulatory interactions and submission execution for ARTBIO’s clinical-stage radiopharmaceutical programs. This role is primarily responsible for coordinating regulatory medical writing across functions. The position works cross-functionally to translate research and development data and strategy into clear, compliant regulatory communications and high-quality submission deliverables. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Bachelor’s degree in a scientific, medical, pharmacy, or related discipline is required, an advanced degree is preferred
- Strong knowledge of US FDA requirements and interaction processes
- Proven track record coordinating US INDs, IND amendments, annual reports, health authority meeting packages, and responses to US FDA information requests
- Hands-on experience with electronic submission publishing, document management, submission standards, and external publishing vendors
- Experience and familiarity with leading submission of New Drug Applications, Marketing Authorization Applications, and radiopharmaceutical development are helpful
More about this role
Summary
The Senior Director, Regulatory Affairs leads and coordinates regulatory interactions and submission execution for ARTBIO’s clinical-stage radiopharmaceutical programs. This role is primarily responsible for coordinating regulatory medical writing across functions. The position works cross-functionally to translate research and development data and strategy into clear, compliant regulatory communications and high-quality submission deliverables.
- Serves as the point of contact for Health Authorities.
- Translates program regulatory strategy into clear interaction plans, submission plans, timelines, and cross-functional deliverables for ARTBIO’s clinical-stage radiopharmaceutical programs.
- Leads the preparation, coordination, and delivery of regulatory submissions, including INDs, IND amendments, annual reports, meeting requests, CTAs, and other lifecycle submissions.
- Schedules and coordinates meeting rehearsals prior to Health Authority interactions.
- Finalizes meeting minutes with Health Authorities, responses to information requests, and follow-up actions.
- Oversees publishing and submissions.
- Partners with Clinical, Medical, CMC, Quality, Nonclinical, Clinical...
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