Senior Director, Regulatory Affairs
New
A
ARTBIOBiopharmaceuticals
Workplace type: RemoteFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 12+ years of progressive regulatory affairs experience in the biotech or pharmaceutical industry
Requirements
- Hold a bachelor’s degree in a scientific, medical, pharmacy, or related discipline.
- Have 12+ years of progressive regulatory affairs experience in the biotech or pharmaceutical industry.
- Demonstrate leadership delivering regulatory interactions for pre-IND to Phase 3 investigational-stage oncology programs.
- Have strong knowledge of US FDA requirements and interaction processes.
- Have experience coordinating US INDs, IND amendments, annual reports, Health Authority meeting packages, and responses to US FDA information requests.
- Have hands-on experience with electronic submission publishing, document management, submission standards, and external publishing vendors.
- An advanced degree is preferred.
- Experience leading New Drug Application and Marketing Authorization Application submissions, and radiopharmaceutical development, is helpful.
Responsibilities
- Serve as the point of contact for Health Authorities.
- Translate regulatory strategy into interaction plans, submission plans, timelines, and cross-functional deliverables.
- Lead preparation, coordination, and delivery of INDs, IND amendments, annual reports, meeting requests, CTAs, and lifecycle submissions.
- Schedule and coordinate meeting rehearsals before Health Authority interactions.
- Finalize Health Authority meeting minutes, responses to information requests, and follow-up actions.
- Oversee submission publishing and delivery.
- Partner with cross-functional 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.
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