Senior Director, Regulatory CMC

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Perspective Therapeutics

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2023

🧬 Biotechnologie

⚕️ Assurance santé

💊 Pharmaceutique

💰 €400 000 Grant en 2024-02

Biotechnology • Healthcare Insurance • Pharmaceuticals

Perspective Therapeutics est une entreprise de biotechnologie spécialisée dans le développement de traitements innovants contre le cancer grâce à une classe unique de théranostiques. Leurs technologies exclusives permettent de cibler des tumeurs spécifiques pour le traitement tout en minimisant la toxicité pour les tissus sains. En utilisant la radiation, les radiopharmaceutiques et des technologies d'imagerie avancées, ils visent à améliorer l'efficacité des traitements et à offrir de meilleurs résultats aux patients atteints de cancer.

Description

• 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.

🎯 Exigences

• 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.

🏖️ Avantages

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