Europe CMC Regulatory Director - Oncology
headcount
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 will collaborate across Development, Quality and Supply Chain to ensure timely, successful global submissions while shaping the strategy #J-18808-Ljbffr
- Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative... ..., we seek a strategic and hands‑on Associate Director, Regulatory Affairs, Europe who will provide regulatory leadership for designated programs...Empfohlen
- 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...Empfohlen
- pBeOne Medicines in Basel, Switzerland seeks a Senior Medical Director Hemato-Oncology in Medical Affairs Europe to lead regional strategies and support lifecycle management for hematology products. /ppThe role requires MD/PhD with 10+ years in biotech/pharma, strong KOL...Empfohlen
- Revolution Medicines is a global oncology company focused on innovative GI cancer therapies. We are seeking a Director, Medical Affairs GI, Europe to lead regional medical strategy for pancreatic and colorectal cancers.You will partner with Global Medical Affairs and cross...Empfohlen
- OverviewMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of CMC Regulatory Affairs. The CMC Regulatory Affairs will serve as a key regulatory strategist and author for the Chemistry...Empfohlen
- ...collaborative, and most importantly, share our passionate interest in fighting cancer. /p pThe Senior Medical Director Hemato-Oncology, Medical Affairs, Europe is the internal key expert within the indication area(s), directly supporting the respective products through...
- ...Medicines is a late-stage clinical oncology company developing novel... ...an experienced Principal Regulatory Medical Writer to support the... ...authorization activities across Europe. Working closely with Regulatory... ..., Pharmacovigilance, CMC, and other cross-functional teams...
- Monte Rosa Therapeutics seeks a seasoned Associate Director of CMC Regulatory Affairs to shape global CMC strategy and author critical submission content. You will collaborate with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply to...
- Revolution Medicines seeks an Associate Director, Regulatory Affairs, Europe to provide strategic regulatory leadership for designated oncology programs across Europe, the EU/EEA, UK and Switzerland. You will align regulatory plans with global goals and drive end-to-end...
- ...Medicines is a global, commercial-state oncology company dedicated to discovering,... ...Reporting to the Executive Director, Medical Affairs GI, Europe, the Director, Medical Affairs GI,... ...Development, Market Access, Commercial, Regulatory, and other cross-functional teams....
- Monte Rosa Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to lead global regulatory strategy for Chemistry, Manufacturing, and Controls across development stages. You will author and review Module 3, coordinate with Process Chemistry, Analytical...
- ...is a global, commercial-state oncology company dedicated to... ...to join our team as Associate Director of Medical Information supporting... ...advancing launch readiness in Europe, while supporting broader Medical... ...compliant with applicable regulatory requirements, industry codes...
- Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering... ...rigor—all in service of patients.The Opportunity:The Director, Internal Communications, Europe, will shape and deliver clear, engaging communications...
- ...Medicines is a late-stage clinical oncology company developing novel targeted... ...Medicines is seeking a Director, Medical Content and Training, Europe, to lead the development, implementation... ...Communications, Clinical Development, Regulatory, Commercial, Legal, Compliance)...
EUR 158400 pro Jahr
...h3Role Purpose /h3 pThe Associate Director, Commercial Training, Europe will define and execute the commercial... ...a continuum of learning for hemato‑oncology field by using actual and... ...Market Access, HR, Compliance, and Regulatory teams to identify needs and co‑create...- Revolution Medicines is seeking an experienced Principal Regulatory Medical Writer to lead the preparation of regulatory documentation for clinical development and marketing authorization across Europe. You will collaborate with Regulatory Affairs, Clinical Development...
EUR 181400 pro Jahr
## Director, RD Counsel, Europe and New MarketsApply: Basel: Germany Remote: Italy Remote: Full time: Posted Today: R37074BeOne continues to grow... ...Legal Compliance to support research, development, regulatory, clinical, safety, medical and related activities. The Director...VollzeitRemote job- BeOne Medicines seeks an experienced Director, RD Counsel to provide strategic legal support for European and New Markets programs across... ...use, privacy and vendor arrangements. You will partner with Regulatory, Clinical Development, Global Clinical Operations and Safety...
- Revolution Medicines, a global oncology company, seeks a Senior Director of Corporate Affairs to lead media relations, corporate public affairs, product... ...markets. The role reports to the VP, Corporate Affairs, Europe, with a focus on aligning local priorities with...
- ...Company | Northwestern Switzerland Build and Lead Internal Regulatory Affairs Capabilities for Late-Stage Development and NDA Filing.... ...Ensure regulatory alignment across clinical, nonclinical and CMC development activities and translate development plans into clear...
- ...importantly, share our passionate interest in fighting cancer. Executive Director, Regional Medical Lead - Solid Tumors, Medical Affairs,... ...within other biotech/pharmaceutical companies. Clinical oncology (hematology or solid tumor) experience; candidates with exceptional...
EUR 133700 pro Jahr
...Basel, Switzerland #onsite /ph3Role Purpose /h3pThe TRD QA Head CMC, ensures quality oversight of the CMC project portfolio and... ...expectations. Strives for a balance between high scientific and regulatory standards. Fosters and implements a culture of smart risk taking...Flexible Arbeitszeit- ...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 commercial...Remote job
- Roche Basel is seeking a Technical Development Leader (TDL) to guide CMC strategies for clinical candidates, leading cross-functional teams from early trials through launch. You will drive scientific integrity, risk management, and seamless collaboration with global teams...
- ...is a temporary position for a period of one year. As a Manager Regulatory Affairs based at our manufacturing site in Visp , you provide end... ...manner. Regulatory Strategy Compliance: Support customers with CMC strategies in alignment with global requirements and customer...Temporär
- Revolution Medicines is seeking an Associate Director of Medical Information to support Europe, including Germany, as launches prepare. You will develop resources... ...and collaborate with cross-functional teams across regulatory, clinical and commercial functions.The role requires...
- Roche Holding AG in Basel sucht eine führende Persönlichkeit als Technical Development Leader (TDL). Sie verantworten die end-to-end CMC-Strategie für klinische Kandidaten und leiten internationale Technical Development Teams, um wissenschaftliche Integrität sicherzustellen...
CHF 169400 pro Jahr
...Executive Clinical Program Leader - Translational Clinical Oncology Location: Cambridge, MA, USA Work Arrangement: Onsite... ...study documents, including protocols, investigator brochures, and regulatory submissions. Contribute scientific and clinical expertise to...VollzeitFlexible Arbeitszeit- Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers... ...ED, Commercial Excellence, Business Analytics and Insights, Europe. Lead commercial launch readiness for oncology products, including...
- Revolution Medicines seeks a highly motivated Medical Science Liaison, Oncology, Switzerland to execute approved field medical plans within a... ..., contribute to medical education, advisory boards, and congress activities under the Medical Director, Switzerland. #J-18808-Ljbffr
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