cmc Jobs in Basel

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...

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 in a high-impact, leadership role.The position demands deep technical expertise in...

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...

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...

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 und Risiken proaktiv zu managen.In dieser strategischen Führungsrolle arbeiten...

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...

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...

ppLocation: Basel, Switzerland #onsite /ph3Role Purpose /h3pThe TRD QA Head CMC, ensures quality oversight of the CMC project portfolio and enabling portfolio within the CMC QA Team. He / she ensures appropriate staffing and prioritization in own area of responsibility. As a leader of Senior QA Associates and local TRD QA Leads, he / she manages resources...

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 ensure compliant, high-quality filings.You will drive Module 3 content, quality summaries,...

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 Development, Drug Product, Quality, and Clinical Supply teams, and interact with health...

pNovartis is seeking a TRD QA Head CMC to oversee quality across the CMC project portfolio and enable portfolio objectives. The role leads Senior QA Associates and local TRD QA Leads, manages resources and budgets, and champions a culture of quality and high performance. /ppThe role drives GMP standards in development with emerging tech, collaborates with...

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, Manufacturing, and Controls components of Monte Rosa's global regulatory filings. This...

Roche Holding AG in Basel sucht eine erfahrene Fachkraft im Bereich Analytical R&D, 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.Sie arbeiten eng mit cross-funktionalen Teams zusammen, identifizieren...

Overview Monte 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, Manufacturing, and Controls components of Monte Rosa's global regulatory...

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure...

Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst....

Monte Rosa Therapeutics, Inc is seeking an Associate Director of CMC Regulatory Affairs to lead global regulatory strategies for Chemistry, Manufacturing, and Controls across development stages. You will author Module 3 content, review summaries, and partner with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply teams to...

Johnson Johnson Innovative Medicine in Allschwil, Switzerland, is recruiting a Principal Scientist, CMC Regulatory Affairs - Combination Products for a hybrid role located in Allschwil. The position focuses on providing regulatory subject matter expertise for drug-device combination products, supporting pre- and post-approval programs, and global lifecycle...

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, Manufacturing, and Controls components of Monte Rosa's global regulatory filings. This...

At 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...