biotech cmc

ph3Director, Regulatory Affairs CMC Europe /h3 pReady to lead the CMC regulatory strategy for novel small-molecule therapies in oncology? /p pWe’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...

pWe are looking for a bGRA CMC Scientist /b to lead strategic and operational CMC regulatory activities across product development, clinical submissions, registrations, and lifecycle management. In this role, you will shape global CMC regulatory strategy, ensure compliant execution of submissions and changes, and partner with technical and regulatory teams...

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...

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...

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...

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 ul liLead EU regulatory strategy and EMA/CHMP engagement, including Scientific...

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...

h3bJob Description /b /h3h3bAbout the role: /b /h3br/ullibDengue vaccine LCM Analytical Oversight: /bSingle point of accountability for the Analytical LCM of Dengue vaccine (dengue tetravalent vaccine). /lilibOwns and drives the Analytical LCM Strategy for Dengue vaccine: /b Deep understanding of the Dengue vaccine product control strategy and works with...

Innovative Biopharmaceutical Company | Northwestern Switzerland Build and Lead Internal Regulatory Affairs Capabilities for Late-Stage Development and NDA Filing. Our client is an innovative, research-driven biotechnology company advancing a portfolio of novel small molecule therapies through late-stage clinical development. As the lead program approaches a...

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...

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...

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...

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...

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...

pRegulatory /p h3Job Description /h3 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...

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...

Regulatory Job Description If 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...