Senior Director, Regulatory CMC

🕒 Junho 13

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Perspective Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2023

🧬 Biotecnologia

⚕️ Seguro de Saúde

💊 Farmacêutico

💰 $400.000 Grant em 2024-02

Biotechnology • Healthcare Insurance • Pharmaceuticals

A Perspective Therapeutics é uma empresa de biotecnologia que se concentra no desenvolvimento de tratamentos inovadores para o câncer por meio de uma classe única de teranósticos. Suas tecnologias proprietárias permitem o direcionamento específico de tumores para tratamento, minimizando a toxicidade para tecidos saudáveis. Ao utilizar radiação, radiofármacos e tecnologias avançadas de imagem, a empresa busca melhorar a eficácia do tratamento e proporcionar melhores resultados para os pacientes com câncer.

Descrição

• Provide strategic leadership for global Chemistry, Manufacturing, and Controls (CMC) regulatory strategy across radiopharmaceutical development programs and future commercial products. • Define and execute CMC regulatory strategies, author and oversee Module 3 and Quality sections of regulatory submissions. • Lead health authority interactions related to CMC, radiochemistry, and manufacturing. • Partner with Manufacturing, Quality, Clinical Development, and Technical Operations to ensure CMC readiness across all stages of development. • Provide expert guidance on global regulatory expectations for CMC, particularly for radiopharmaceuticals. • Ensure CMC documentation is scientifically robust, compliant, and aligned with clinical and manufacturing strategy. • Provide leadership on regulatory approach for CMC changes, comparability assessments, process changes, site transfers, and manufacturing evolution.

🎯 Requisitos

• Bachelor’s degree in a scientific discipline required; advanced degree (PhD, MS, or equivalent) in chemistry, pharmaceutical sciences, radiochemistry, or related field strongly preferred. • Minimum of 12+ years of progressive Regulatory Affairs experience, with significant focus on CMC regulatory strategy and submissions. • Significant hands-on experience in radiopharmaceutical CMC regulatory affairs is required, including support for radiochemistry, manufacturing controls, and quality strategy for clinical and/or commercial programs. • Experience with alpha-emitting radiopharmaceuticals and peptide-based products is strongly preferred. • Demonstrated success leading CMC sections of major global regulatory submissions, including INDs, CTAs/IMPDs, and marketing applications. • Extensive experience interacting with global regulatory agencies (e.g., FDA, EMA), including leading preparation for and participation in formal meetings (e.g., Type B, Type C). • Strong experience working cross-functionally with Manufacturing, Technical Operations, and Quality organizations. • Experience with CMC change management, comparability, site transfers, technical transfers, and/or commercialization readiness strongly preferred. • Experience working with internal and external manufacturing networks, including CDMOs and contract testing laboratories, strongly preferred.

🏖️ Benefícios

• Remote, home-based position • Flexibility to support meetings across time zones • Professional development opportunities • Equal employment opportunities