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- ...meaningful progress. and a place on The Sunday Times Best Places to Work list in the UK. We’re looking for a Senior Director, Regulatory Affairs CMC - Gene Therapy to help us expand what’s possible for patients with serious diseases. Reporting to the VP, Regulatory...RegulatoryLocal areaRemote workFlexible hours
- ...products that address significant unmet need in oncology and rare diseases. Stay Connected with Telix for Future or Upcoming Regulatory Affairs - CMC Opportunities Telix is always looking to connect with great talent in the market! While we may not have the position...RegulatoryFull timeRemote work
- Stoke Therapeutics is seeking a Regulatory CMC Manager to drive global regulatory CMC strategies across multiple programs. You will collaborate with cross-functional teams including Regulatory Affairs and Technical Operations to navigate FDA/EMA requirements. The role...RegulatoryRemote job
$180k - $230k
...partner company, who manages all applications and next steps. Our partner is looking for a Director - US RA CMC Team Leader & Innovation, Global CMC Regulatory Affairs based in the United States. The Director will lead the US CMC Regulatory Affairs team while shaping...RegulatoryFull timeRemote work- Scorpion Therapeutics seeks an Associate Director, CMC Regulatory Affairs to provide strategic and operational leadership for global regulatory activities spanning development to commercialization of small molecule oral solid dosage forms. The role leads CMC submissions...RegulatoryRemote job
- Parexel is seeking a CMC Strategy Senior Associate / Consultant to lead and contribute to regulatory strategies for biologics and vaccines, spanning US, EU, and beyond. You will author and review CMC documentation, support global submissions, and perform dossier gap analyses...RegulatoryRemote job
- CMC Specialist The CMC Specialist in Regulatory Affairs is responsible for overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of regulatory submissions for pharmaceutical products. This role involves collaborating with cross-functional teams to ensure compliance...RegulatoryRemote work
$175.5k - $283.8k
...listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Director, Regulatory CMC based in the United States. We are seeking an accomplished Senior Director, Regulatory CMC to lead global Chemistry,...RegulatoryFull timeContract workRemote workFlexible hours- Scorpion Therapeutics seeks a Senior Manager, CMC Regulatory Affairs to lead regulatory strategy for biologic drug development and lifecycle management. You will drive global CMC submissions and health authority interactions, enabling late-stage programs and rare indications...RegulatoryRemote job
$150k - $210k
...you’re looking to do work that matters, we’d love to hear from you. About the Position: This position will contribute regulatory CMC experience to Edgewise cardiovascular therapeutic development teams. Essential Job Duties and Functions: Responsible...RegulatoryFull timeFor contractorsRemote work$210k - $300k
...About Opus Regulatory: Founded in 1994, Opus Regulatory (Opus) is a specialist consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo. Our clients range from development-stage biotech companies to mid-size and large pharmaceutical organizations...RegulatoryFull timeTemporary workRemote work$222k - $303k
...for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for a Senior Director, Regulatory Affairs CMC to help us expand what’s possible for patients with serious diseases. Reporting to the VP, Regulatory Affairs CMC, the...RegulatoryLocal areaRemote workWorldwideFlexible hours- Cardinal Health, Inc. is seeking a Scientist III CMC to lead regulatory strategy for pre- and post-approval activities and to author pivotal CMC documents. You will collaborate with cross-functional teams across global manufacturing and QA to ensure robust submissions...RegulatoryRemote job
- Kite Pharma, Inc. is seeking a Manager of Regulatory Affairs CMC to lead regulatory activities for lentiviral vector (LVV) based cell therapies. The role is office-based with hybrid eligibility and located in the United States (Philadelphia, PA; Thousand Oaks/El Segundo...RegulatoryWork at officeRemote workRelocation
- ...seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing with Travere CDMOs. This role partners with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure milestone alignment...RegulatoryRemote job
$230k - $270k
...at greater scale to more patients. About the role: Allogene Therapeutics is seeking a highly motivated Senior Director, CMC Regulatory Affairs in the Global Regulatory Affairs and Clinical Quality group to support products under development and lead CMC product...RegulatoryContract workInternshipLocal areaRemote work2 days per weekAllogene Therapeutics
South San Francisco, CA2 days ago- Role: Associate Director, CMC Regulatory Affairs, providing strategic and operational leadership for regulatory activities related to small molecule drug products, primarily oral solid dosage forms, from development through commercialization. Responsibilities develop and...RegulatoryRemote work
- ...technologies. For more information, visit Position: Manager, CMC Quality Summary: The Manager, CMC Quality will... ...cross-functional teams. Partner with CMC, Supply Chain, and Regulatory Affairs to assess product quality impact of events, identify product...RegulatoryFull timeContract workLocal area
- ...hybrid) seeks a Senior Director, Technical Operations to lead the CMC strategy for a diverse portfolio of small molecules in... ...manufacturing. You will oversee external CMOs, coordinate with Quality, Regulatory Affairs, Clinical, and Supply Chain, and drive risk mitigation...RegulatoryRemote job
- ...aspirations. Join Kite and help create more tomorrows.Job DescriptionThis is an office based/hybrid position. The Manager, Regulatory Affairs CMC is located in El Segundo, CA, Thousand Oaks, CA, Foster City, CA or Parsippany, NJ. Kite is transitioning from its current...RegulatoryFull timeContract workFor contractorsWork at officeLocal areaRemote workRelocationFlexible hours
GILEAD Sciences
San Mateo, CA4 days ago - ...goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution... ...Heart ®. About the Role We are seeking an experienced CMC regulatory professional to join our team as a Senior Regulatory...RegulatoryFull timeRemote workWorldwideFlexible hours
$204.5k - $274.5k
...behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Director, Regulatory Affairs, CMC based in the United States. As Senior Director, Regulatory Affairs, CMC, you will lead global Chemistry, Manufacturing,...RegulatoryFull timeRemote workWorldwideFlexible hours$193.1k - $289.7k
Job DescriptionGeneral Summary:The CMC Statistics Director (Scientific Fellow) provides strategic and technical leadership for the... ...continued process verification (CPV), stability, quality control, and regulatory submissions. This individual will establish and lead the CMC...RegulatoryFull timeSummer workRemote workFlexible hours2 days per weekVertex Pharmaceuticals
Boston, MA3 days ago$190k - $237k
...Director, Regulatory Affairs, CMC Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building...RegulatoryWork at officeRemote workSummit Therapeutics
United States3 days ago$185k - $256k
...looking for an experienced market leader, thought leader and SME in CMC Chemistry, Manufacturing, and Controls) . CMC leaders carry... ...MSAT, Pharmaceutical Sciences, Global Supply and Quality, and Regulatory CMC Build positioning and messaging that speaks to...RegulatoryFull timeWork experience placementImmediate startRemote workFlexible hours- ...Revolution Medicines seeks a Director of Global CMC Regulatory to lead commercial chemistry, manufacturing, and controls regulatory strategy for its oncology product portfolio. The role involves developing and executing global marketing approval strategies, managing health...Regulatory
Revolution Medicines
Remote24 days ago $201k - $251k
...with urgency and hold ourselves to a high standard of rigor—all in service of patients. The Opportunity The Director, CMC Regulatory (post-approval) is responsible for providing strategic, hands-on and operational leadership for global post-approval submissions...RegulatoryFull timeLocal areaRemote workWorldwide- ...goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution... ...the Role We are seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity based. As a Regulatory...RegulatoryFull timeContract workLocal areaRemote workWorldwideFlexible hours
- ...leading innovation, With Heart. About the Role We are seeking a Chemistry, Manufacturing, and Controls (CMC) Strategy Senior Associate / Consultant (CMC Regulatory Affairs) to join our team in a remote capacity. As a CMC Strategy Senior Associate / Consultant, you will...RegulatoryRemote workWorldwide
$222k - $303k
...for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for a Senior Director, Regulatory Affairs CMC – Gene Therapy to help us expand what’s possible for patients with serious diseases. Reporting to the VP, Regulatory...RegulatoryFull timeLocal areaRemote workFlexible hours
