biotech 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...

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 Vifor in Bern seeks two GRA CMC Scientists to be based in Bern, Switzerland, or at sites in the US or Australia. You will develop global CMC regulatory strategies for biologics, coordinate regulatory documentation, and support submissions and inspections. /ppIdeal candidates have 3+ years in biotech/pharma, with experience in regulatory affairs, CMC,...

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...

CSL in Glattbrugg, Switzerland, seeks an experienced Clinical Development professional to provide scientific input to development strategies and program design. The role is onsite three days per week.You will guide trial design, contribute to regulatory submissions, author study documents, and mentor project teams while collaborating across departments. With...

pA Senior regulatory leader responsible for bEU regulatory strategy and execution /b across oncology and non-oncology development programmes, acting as the EU/Global Regulatory Lead from early development through approval and lifecycle management. /p h3Key Responsibilities /h3 ulliLead EU regulatory strategy and EMA/CHMP engagement, including Scientific...

CSL Behring in Glattbrugg, Switzerland is seeking a senior clinical development professional to provide scientific input to development strategies and program execution. You will shape the scientific strategy across multiple program components and author critical trial-related documents.This onsite role requires 8+ years in biotech/pharma, 5+ years managing...

Job DescriptionDesign, implement, and maintain CMC data standards, taxonomies, and ontologies for the biologics modality.Ensure high-quality, contextualized, and analysis-ready CMC process data to enable MSAT and manufacturing use cases.Translate global CMC data strategy into practical implementation, including SOPs and business rules.Act as a subject matter...

A Senior regulatory leader responsible for EU regulatory strategy and execution across oncology and non-oncology development programmes, acting as the EU/Global Regulatory Lead from early development through approval and lifecycle management. Key Responsibilities Lead EU regulatory strategy and EMA/CHMP engagement, including Scientific Advice. Oversee CTA...

We are currently looking for a Global Regulatory Affairs CMC Manager to join our teams in Bern, Switzerland or Waltham, US on a permanent basis. **Main Responsibilities And Accountabilities** - The Global Regulatory Affairs (GRA) CMC Manager is responsible to work in an efficient, productive and harmonized fashion to be the CMC regulatory subject...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality.Every member of our Madrigal team is connected by our shared purpose: leading the fight...

ppMadrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. /ppEvery member of our Madrigal team is connected by our shared purpose: leading the...

Career CategoryRegulatoryJob DescriptionIf you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight...

pbLocation: the actual location of this job is in Visp, Basel, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. This is a temporary position for a period of one year. /b /ppAs a bManager Regulatory Affairs based at our manufacturing site in Visp /b, you provide end-to-end regulatory leadership for complex...

pIf you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that read over...

ppLocation: the actual location of this job is in Visp, Basel, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. This 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-to-end regulatory leadership for complex client...

pSwitzerland, Basel /p pSwitzerland, Visp /p pbLocation: the actual location of this job is in Visp, Basel, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. This is a temporary position for a period of one year. /b /p pAs a bManager Regulatory Affairs based at our manufacturing site in Visp /b, you...

Switzerland, Basel Switzerland, Visp Location: the actual location of this job is in Visp, Basel, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. This 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-to-end...

ppbThe Role What You Will Be Doing /b /p pThe Expert Medical Writer provides strategic, scientific, and operational leadership for the planning, authoring, and coordination of high-impact clinical and regulatory documents that support global marketing applications. In addition to hands‑on writing, the role serves as Programme Medical Writer for complex...