Senior Manager, Regulatory Affairs CMC

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Spyre Therapeutics

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11 - 50 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

Biotechnology • Pharmaceuticals

Spyre Therapeutics ist ein biopharmazeutisches Unternehmen, das sich auf die Entwicklung von Therapien für entzündliche Darmerkrankungen (IBD) konzentriert. Das Unternehmen setzt sich dafür ein, erstklassige Antikörper, rationale therapeutische Kombinationen und präzise Immunologieansätze zu schaffen, um die Wirksamkeit und den Komfort der Behandlung für IBD-Patienten zu verbessern. Mit einem erfahrenen Team, das Behandlungen für verschiedene Krankheiten entwickeln und vermarkten kann, widmet sich Spyre Therapeutics der Verbesserung von Behandlungsoptionen und Ergebnissen für Patienten durch fortgeschrittene Forschung in der Immunologie. Das Unternehmen fördert ein kooperatives und innovatives Umfeld, um seine Mission zu erreichen, vielversprechende neue Behandlungsoptionen für IBD bereitzustellen.

Beschreibung

• Act as the Reg CMC lead for assigned programs, driving strategy, execution, and timelines. • Personally author sections of Module 2 and 3 (QOS, drug substance, drug product, comparability, stability, etc.). • Own CMC regulatory deliverables end-to-end with minimal oversight. • Lead and deliver global submissions (INDs, IMPDs, CTAs, amendments, annual reports) with a focus on timeliness, quality, and completeness. • Identify risks early and lead teams to resolution to keep programs on track. • Translate complex technical data into clear and concise narratives. • Lead preparation of CMC-related responses to HA questions. • Act as a connector and leader in discussions, not a passive participant. • Manage multiple programs, while prioritizing effectively. • Other duties as assigned.

🎯 Anforderungen

• Bachelor’s degree with a minimum of 5+ years of experience in CMC regulatory affairs, supporting clinical-stage biologics programs (or equivalent combination of education and experience). • Experience as the primary CMC regulatory lead for clinical stage programs (EU CTR and ROW experience is a plus). • Hands-on authoring experience for IND and IMPD submissions and amendments, including direct responsibility for authoring CMC sections. • Exceptional technical writing skills, with the ability to clearly communicate complex technical information in regulatory documents and health authority responses. • Proven experience preparing responses to CMC health authority questions during clinical development. • Strong understanding of global CMC regulatory requirements and guidelines including FDA, EMA, and ICH. • Strong attention to detail, organizational skills, and the ability to manage multiple concurrent submissions and timelines in a fast-paced environment. • Excellent written and verbal communication skills, with the ability to collaborate effectively across technical and cross-functional teams. • Proficiency with regulatory submission and document management systems (e.g., Veeva RIM, eCTD publishing platforms, document repositories).

🏖️ Vorteile

• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits. • Unlimited PTO • Two, one-week company-wide shutdowns each • Commitment to provide professional development opportunities. • Remote working environment with frequent in-person meetings to address complex problems and build relationships.