cmc regulatory

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...

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,...

pMonte 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. /ppYou will drive Module 3 content, quality...

Monte Rosa Therapeutics, Inc. is seeking an Associate Director of CMC Regulatory Affairs to lead global regulatory strategy for Chemistry, Manufacturing and Controls.You will author Module 3 submissions, coordinate with Process Chemistry, Analytical Development, Drug Product, Quality, and Clinical Supply teams, and represent CMC in health authority...

pMonte 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...

pMonte 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...

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...

h3Work Schedule /h3 pStandard (Mon-Fri) /p h3Environmental Conditions /h3 pOffice /p h3Job Description /h3 pJoin our global Regulatory Affairs team in a client-dedicated role supporting commercial medicinal products used in clinical trials, including comparator and auxiliary medicinal products. /p pThis highly client-facing position combines bEU/EEA...

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join our global Regulatory Affairs team in a client-dedicated role supporting commercial medicinal products used in clinical trials, including comparator and auxiliary medicinal products. This highly client-facing position combines EU/EEA regulatory assessment, CMC and labelling...

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionJoin our global Regulatory Affairs team in a client-dedicated role supporting commercial medicinal products used in clinical trials, including comparator and auxiliary medicinal products.This highly client-facing position combines EU/EEA regulatory assessment, CMC and labelling...

Sintetica, founded in 1921 and based in Mendrisio, Switzerland, seeks a CMC Senior Specialist to manage CMC activities for drug product registrations, lifecycle management, and regulatory compliance throughout the product lifecycle. You will prepare and maintain CMC documentation and serve as the focal point for regulatory interactions.Reporting to the CMC...

Lonza Group in Visp, Switzerland, is seeking a Manager Regulatory Affairs to lead end-to-end regulatory activities for complex client programs at the Visp site. You will shape regulatory strategy and ensure timely, compliant delivery across global networks.You will act as trusted regulatory advisor to cross-functional teams, coordinating submissions,...

pLonza Group in Visp, Switzerland, is seeking a Manager Regulatory Affairs to lead end-to-end regulatory activities for complex client programs at the Visp site. You will shape regulatory strategy and ensure timely, compliant delivery across global networks. /ppYou will act as trusted regulatory advisor to cross-functional teams, coordinating submissions,...

OverviewThe Manager/Senior Manager*, Regulatory Affairs, CMC will primarily be responsible for supporting / managing regulatory CMC submissions and strategy for Incyte development and marketed products, including both small molecules and biologics, from early development through late-stage (phase 3, registration and post-approval).Duties and...

Lonza Group Ltd. is seeking a Manager of Regulatory Affairs at our Visp site in Switzerland.The role leads end-to-end regulatory activities for complex client programs, coordinating timelines and deliverables with global RA networks to ensure timely, compliant regulatory milestones. You will build regulatory strategies aligned with global requirements,...

pLonza Group Ltd. is seeking a Manager of Regulatory Affairs at our Visp site in Switzerland. /ppThe role leads end-to-end regulatory activities for complex client programs, coordinating timelines and deliverables with global RA networks to ensure timely, compliant regulatory milestones. You will build regulatory strategies aligned with global requirements,...

h3Senior Manager / Associate Director, Regulatory Strategy - CMC /h3 h3Location: Basel /h3 pMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our teams. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible for developing and implementing...

ph3Overview /h3pMonte 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....

Lonza Group Ltd. is seeking a Manager of Regulatory Affairs at our Visp site in Switzerland.The role leads end-to-end regulatory activities for complex client programs, coordinating timelines and deliverables with global RA networks to ensure timely, compliant regulatory milestones. You will build regulatory strategies aligned with global requirements,...

ph3Overview /h3pMonte 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....