Head of Regulatory Affairs

🕒 vor 2 Monaten

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

⏰ Vollzeit

🔴 Experte

🚔 Compliance

👻 Geisterscore 28%

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ARTBIO

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51 - 200 Mitarbeiter

🏭 Fertigung

📦 Logistik

🧬 Biotechnologie

💰 €90.000.000 Series A im 2023-12

Manufacturing • Logistics • Biotechnology

ARTBIO ist ein Radiopharma-Biotechnologieunternehmen in der klinischen Entwicklungsphase, das sich auf die Entwicklung einer neuen Klasse von Alpha-Radioligandentherapien (ART) konzentriert. Der einzigartige patientenzentrierte Ansatz basiert auf einem tiefgreifenden Verständnis der Krebsbiologie sowie auf der erforderlichen Infrastruktur, um die Therapien effektiv zu entwickeln, herzustellen und zu vertreiben.

Beschreibung

• Define and lead global regulatory strategy for ARTBIO’s clinical-stage radiopharmaceutical programs • Lead key regulatory submissions, including INDs, CTAs, and DMFs • Lead FDA and global health authority interactions, including meeting preparation, briefing packages, responses, and follow-up actions • Ensure compliance with regulatory requirements throughout the drug development lifecycle, including clinical trials and manufacturing • Proactively identify potential regulatory risks and develop mitigation strategies • Identify regulatory risks and advise executive leadership on timelines and decision points • Partner with Clinical, CMC, Quality, Nonclinical, Clinical Development and Operations, regulatory consultants, and external publishing partners to support timely, high-quality submissions • Serve as the primary point of contact for regulatory agencies and build strong relationships with key regulatory authorities • Monitor regulatory policy changes and provide practical guidance to internal teams on requirements, risks, and opportunities • Build regulatory capability through team leadership, mentoring, training, and strong cross-functional collaboration

🎯 Anforderungen

• 15+ years of regulatory affairs experience in the biotech or pharmaceutical industries, with emphasis on drug development • In-depth knowledge of global regulatory requirements and guidelines, including FDA and EMA regulations and international regulatory frameworks • Proven track record of successful regulatory submissions, including INDs, NDAs, BLAs and MAAs • Experience leading regulatory affairs strategies for complex programs across multiple therapeutic areas • Strong understanding of drug development processes, CMC, quality, and clinical trial regulations • Demonstrated ability to navigate complex regulatory landscapes and anticipate and mitigate potential regulatory risks • Familiarity with radiopharmaceuticals is a plus • Advanced degree (JD, PhD, PharmD, MD or equivalent) in a scientific discipline is preferred • Proactive, detail-oriented, and eager to learn • Comfortable working in a fast-paced biotech environment • Team player who thrives on collaboration and cross-functional flexibility • Commitment to safety and continuous improvement

🏖️ Vorteile

• 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

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