Senior Director, Regulatory Affairs

Job not on LinkedIn

🔥 1 hour ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ARTBIO

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏭 Manufacturing

📦 Logistics

🧬 Biotechnology

💰 $90M Series A on 2023-12

Manufacturing • Logistics • Biotechnology

ARTBIO is a clinical-stage radiopharmaceutical biotechnology company focused on developing a new class of alpha radioligand therapies (ART). Their unique patient-centric approach is underpinned by a deep understanding of cancer biology and the infrastructure needed to effectively design, manufacture, and distribute their therapies.

📋 Description

• 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

🎯 Requirements

• Bachelor’s degree in a scientific, medical, pharmacy, or related discipline is required; an advanced degree is preferred • 12+ years of progressive regulatory affairs experience in the biotech or pharmaceutical industry • Leadership in regulatory interaction deliverables supporting pre-IND to Phase 3 investigational-stage oncology programs • 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 leading submission of New Drug Applications and Marketing Authorization Applications is helpful • Familiarity with radiopharmaceutical development is helpful • Clear, concise communication with strong scientific judgment and exceptional writing and editing skills • Highly organized, proactive, and detail-oriented, with disciplined follow-through on commitments and timelines • Comfortable working in a fast-paced biotech environment with evolving priorities and multiple stakeholders • Collaborative leadership and ability to align subject matter experts, challenge constructively, and drive decisions • Commitment to quality, compliance, and patient safety

🏖️ Benefits

• A unique chance to contribute to first-in-class cancer therapies • Exposure to both radiochemistry and CMC development in a dynamic biotech setting • Hands-on training and professional development opportunities • An international, collaborative, and supportive work culture • Competitive compensation and benefits