Director, Global Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC), Platform Innovation – Small Molecules

🕒 vor 1 Monat

🇺🇸 Vereinigte Staaten – Remote

💵 $148.500 - $257.400 / Jahr

⏰ Vollzeit

🔴 Experte

🚔 Compliance

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Eli Lilly and Company

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10.000+ Mitarbeiter

Gegründet 1876

💊 Pharmazie

Pharmaceuticals

Wir sind ein Arzneimittelunternehmen, das Wissenschaft in Heilung verwandelt, um das Leben von Menschen auf der ganzen Welt zu verbessern. Alles begann vor fast 150 Jahren mit der klaren Vision unseres Gründers Colonel Eli Lilly: „Nehmen Sie, was Sie hier finden, und machen Sie es immer besser.“ Indem wir die Kraft der Biotechnologie, Chemie und genetischen Medizin nutzen, treiben unsere Wissenschaftler die Wissenschaft mit Nachdruck voran, um einige der bedeutendsten gesundheitlichen Herausforderungen der Welt zu lösen.

Beschreibung

• Provide strategic, tactical and operational regulatory CMC leadership across therapeutic modalities and manufacturing technologies to expedite development of the small molecule portfolio. • Support clinical trial applications, market registrations, and post approval submissions. • Knowledge of global regulations, guidelines, and regulatory precedent coupled with deep technical knowledge of CMC development and manufacturing processes. • Development and implementation of innovative regulatory strategies and platform approaches based on changes in external environment. • Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planning. • Lead preparation, critical review, and approval of CMC documents for global regulatory submissions and responses. • Takes a proactive leadership role in the critical review of molecule specific CMC development and lifecycle strategies. • Provide high quality, timely and clear regulatory advice to project teams.

🎯 Anforderungen

• B.S. degree in a science, engineering, or a STEM related field (advanced degree preferred). • 10+ years of Regulatory CMC or technical CMC experience supporting clinical phases of development and/or commercialization of synthetic molecules. • Experience authoring CMC submission content and involvement in clinical trial applications/marketing authorization application processes including response to questions. • Knowledge of major market procedures, regulations, and practices. • Relevant experience in synthetic molecule drug substance and/or drug product development, commercialization, or manufacturing. • Demonstrated deep knowledge of the synthetic molecule drug development process. • Extensive prior regulatory experience handling complex regulatory submission strategies or equivalent combination of technical and regulatory guidance knowledge and experience. • Experience planning for and participating in Health Authority meetings. • Demonstrated ability to assess and manage risk in a highly regulated environment. • Demonstrated strong written, spoken and presentation communication skills. • Demonstrated leadership behaviors and negotiation and influence skills. • Demonstrated attention to detail. • Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.

🏖️ Vorteile

• Eligibility for a company bonus (depending on company and individual performance) • 401(k) • Pension • Vacation benefits • Eligibility for medical, dental, vision and prescription drug benefits • Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts) • Life insurance and death benefits • Certain time off and leave of absence benefits • Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)