cmc

Director, Regulatory Affairs CMC Europe Ready to lead the CMC regulatory strategy for novel small-molecule therapies in oncology? We’re partnering with an innovative biotechnology company that is advancing a portfolio of next-generation targeted oncology therapies. As the pipeline progresses towards global registrations, we’re looking for an experienced...

ph3Position Purpose /h3pPartnering closely with global and regional Global Regulatory Affairs colleagues, as well as Global Operations stakeholders, to address regulatory strategy challenges and deliver innovative, timely regulatory CMC solutions that meet evolving regulatory and compliance requirements. Supporting digital innovation, enabling capital...

ppNotre client, une entreprise biopharmaceutique internationale basée à Bâle, développe et fabrique des biologics et petites molécules pour des marchés soumis à EU/FDA/Swissmedic. Pour renforcer l’équipe Regulatory CMC, nous recherchons un(e) Responsable Affaires Réglementaires CMC capable de piloter la stratégie dossier de la clinique au...

pCSL Behring seeks a senior Regulatory CMC leader to drive global strategy, coordinate with Global Regulatory Affairs and Global Operations, and advance digital initiatives across the enterprise. /ppThe role requires 5+ years in regulatory affairs for biologics or plasma, with strong leadership, communication, and vendor-management skills to ensure timely,...

Headcount is seeking a Director of Regulatory Affairs CMC Europe to lead the regulatory strategy for novel small-molecule therapies in oncology. This role requires steering global CMC development, submissions and lifecycle management across clinical, regulatory and manufacturing functions, with a focus on Module 3 and interactions with FDA/EMA.The candidate...

pJohnson Johnson Innovative Medicine is seeking a Principal Scientist (Manager) for Global Regulatory Affairs, CMC, responsible for global CMC regulatory strategies for large molecules from clinical development through post‑marketing. You will lead regulatory dossiers and guide cross‑functional teams to ensure compliant, timely submissions across global...

pGpcsa, entreprise biopharmaceutique à Bâle, recherche un(e) Responsable Affaires Réglementaires CMC. Ce poste stratégique nécessite de définir et exécuter la stratégie CMC pour garantir la cohérence du dossier avec les exigences réglementaires. /ppLe candidat devra avoir 6 à 10 ans d'expérience dans le domaine, une maîtrise du CTD et des...

ppDu kennst CMC-Dossiers in- und auswendig – und weisst genau, worauf es in Modul 3 ankommt? /ppDann haben wir die richtige Aufgabe für dich. Als Teil eines bglobal aufgestellten CMC RA Teams /b übernimmst du die regulatorische Bearbeitung für den beuropäischen Raum und die Schweiz /b – hands-on, präzise und eigenverantwortlich. /ph3Auf einen Blick:...

ppAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the...

ppAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the...

Position PurposePartnering closely with global and regional Global Regulatory Affairs colleagues, as well as Global Operations stakeholders, to address regulatory strategy challenges and deliver innovative, timely regulatory CMC solutions that meet evolving regulatory and compliance requirements.Supporting digital innovation, enabling capital project...

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target...

gloor&lang AG in Basel seeks a senior Regulatory Affairs CMC expert to lead global CMC strategy for development and registration of small molecule therapies, shaping regulatory submissions (Module 3) and lifecycle management in collaboration with CMC Development, Analytical Development, Manufacturing and Quality.You will guide IND, NDA and MAA submissions,...

Innovative Biopharmaceutical Company in Northwestern Switzerland is seeking an experienced Regulatory Affairs CMC professional to shape global regulatory strategy for innovative small molecule therapies.You will lead CMC activities across clinical development through registration, preparing Module 3 documentation and coordinating submissions with FDA, EMA...

RhyGaze is a biotech company developing transformative gene therapies to restore vision in patients with blindness. Our programs target patients with blinding retinal diseases, and we are committed to bringing life-changing treatments to those in need.We are seeking an experienced and highly motivated Associate Director/Director of Analytical Development to...

pRoche Holding AG in Basel sucht eine erfahrene Fachkraft im Bereich Analytical RD, um fachliche Führung zu übernehmen und NDA-Prozesse zu steuern. Sie bringen tiefe Kenntnisse in der analytischen Entwicklung von Parenteralia und in der Transferlogik zur kommerziellen Herstellung mit. /ppSie arbeiten eng mit cross-funktionalen Teams zusammen,...

pJohnson Johnson is seeking a Principal Scientist (Manager) in Global Regulatory Affairs, CMC, to lead regulatory strategy for complex biologics and devices. This onsite/hybrid role requires deep regulatory expertise and collaboration across global teams to ensure timely product development and lifecycle management. /ppCandidates should hold a BS/BA in a...

pJohnson Johnson Innovative Medicine in Allschwil, Switzerland, is seeking a Principal Scientist to lead global CMC regulatory strategies for large molecules. You will shape dossiers, plans, and interactions with authorities across development and lifecycle management. /ppThe role requires strategic thinking, strong writing and communication,...

Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease,...

pRhyGaze is a biotech company developing transformative gene therapies to restore vision in patients with blindness. Our programs target patients with blinding retinal diseases, and we are committed to bringing life-changing treatments to those in need. /p pWe are seeking an experienced and highly motivated Associate Director/Director of Analytical...