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- ...About Freyr Freyr is a global Regulatory Affairs and Life Sciences consulting organization supporting pharmaceutical, biotechnology, medical... ...Job Title: Sr Manager, Global Regulatory Affairs Strategist CMC Job Type: Permanent Job Location: Princeton NJ, - Remote...RegulatoryPermanent employmentFull timeLocal areaRemote workFlexible hours
Freyr Solutions
Princeton, NJ1 day ago $147.5k - $221.3k
Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection... ...and governance forumsKnowledge and Skills:Knowledge of regulatory requirements and inspection expectations globallyExperience in...RegulatoryFull timeSummer workRemote workFlexible hours2 days per weekVertex Pharmaceuticals
Boston, MA1 day ago$166.4k - $249.6k
Job DescriptionGeneral Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products focusing on biologics. This role is accountable for authoring, reviewing, and...RegulatoryFull timeSummer workRemote workFlexible hours2 days per weekVertex Pharmaceuticals
Boston, MA3 days ago$142.5k - $256.5k
The Role:The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle. The Associate Director will be responsible for developing...RegulatoryPermanent employmentFull timeWork at officeWork from homeModerna Therapeutics
Norwood, MA2 days ago- ...ProKidney Corp. is seeking a Director of CMC Project Management to lead CMC planning for late-stage and commercial submissions. You... ...-on leadership across manufacturing, quality, analytical and regulatory areas with a focus on risk mitigation. You will report to the VP...RegulatoryRemote job
$190.4k - $285.6k
Job DescriptionGeneral Summary:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory strategies across multiple investigational and commercial products in the small molecule portfolio....RegulatoryFull timeSummer workRemote workFlexible hours2 days per weekVertex Pharmaceuticals
Boston, MA5 days ago$184.6k - $277k
Job DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for inspection readiness and compliance of internal... ...manufacturing/testing sites. Monitor and interpret cGMP regulatory guidelines and trends in the regulatory space and incorporate into...RegulatoryFull timeWork experience placementSummer workRemote workFlexible hours2 days per weekVertex Pharmaceuticals
Boston, MA1 day ago- ...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
Santa Monica, CA3 days ago $177k - $278.08k
...possible in order to bring life-changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows...RegulatoryMinimum wageLocal areaRemote workWorldwideTakeda
Boston, MA4 days ago$132k - $172k
...paths as we move toward a common goal of elevating science and service for rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls...RegulatoryFull timeTemporary workRemote workWorldwideTravere Therapeutics
San Diego, CA1 day ago- ...patient advocacy and care. Discover more here.Who we are looking forThis is what you will doCurrently seeking a Regulatory Affairs (RA) Manager with strong CMC pre and post approval experience to support Chiesi’s Global Rare Diseases (GRD) global portfolio of commercial...RegulatoryHourly payWork at officeLocal areaRemote workRelocation packageFlexible hours
Chiesi
Cary, NC1 day ago $143.23k - $185.35k
...and three days working onsite.Key ResponsibilitiesRegulatory Strategy and Program LeadershipLead or support integrated global CMC regulatory strategies for both T-cell drug product and LVV, with clear differentiation between early-stage, pivotal/late-stage, registration...RegulatoryFull timeFor contractorsWork at officeLocal areaRemote workRelocationFlexible hoursKite Pharma
Foster, CA2 days ago$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, MA5 days ago$143.23k - $185.35k
...developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.Job DescriptionThe Senior Manager, Regulatory Affairs CMC supports and drives increasingly complex CMC regulatory activities for Kite’s cell therapy / CAR-T portfolio across...RegulatoryFull timeFor contractorsWork at officeLocal areaRemote workRelocationFlexible hoursShift workGILEAD Sciences
Santa Monica, CA4 days ago- ...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
$246.98k - $299.29k
...personal lives. Read more: careers.bms.com/working-with-us.The GRS-CMC Director is responsible for overseeing management of multiple... .... Develop and communicate strategic direction based on global regulatory guidelines and experience. Seeks opportunities for external...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift workRayzeBio
San Diego, CA4 days ago$150k - $195k
...paths as we move toward a common goal of elevating science and service for rare patients.Position Summary:The Associate Director, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls...RegulatoryFull timeTemporary workRemote workTravere Therapeutics
San Diego, CA4 days ago$258.83k - $293.48k
...strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.The Senior Director of Regulatory Affairs CMC provides highly strategic, tactical and operational regulatory CMC leadership to support clinical trial applications,...RegulatoryMinimum wageFull timeWork at officeLocal areaFlexible hours3 days per weekMadrigal Pharmaceuticals
Conshohocken, PA3 days ago$150k - $195k
...Summary:The Associate Director, Technical Operations (Small Molecule CMC) will provide technical oversight for small molecule API... ...drug products.This individual will partner closely with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure alignment, risk...RegulatoryFull timeContract workTemporary workRemote workTravere Therapeutics
San Diego, CA4 days ago$75 - $80 per hour
...position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Device Regulatory CMC - Manager based in United States. This role supports global regulatory CMC activities for marketed and development-stage...RegulatoryHourly payContract workTemporary workRemote workjobgether
United States2 days ago- ...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
$142.5k - $256.5k
The RoleModerna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, governing CMC submissions, and providing...RegulatoryPermanent employmentFull timeWork at officeWork from homeModerna Therapeutics
Norwood, MA3 days ago$56.4k - $115.1k
Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization...RegulatoryFull timeContract workFlexible hours$207k - $253k
## Director, Regulatory Affairs CMCApplylocations: MA - Waltham - Officetime type: Full timeposted on: Posted 3 Days Agojob requisition id... ...role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations...RegulatoryMinimum wageFull timeLocal areaFlexible hoursMadrigalpharma
Waltham, MA2 days ago$167k - $300.7k
...Digital Operations and Strategic Portfolio Management, the Director, CMC Digital Operations and Strategic Portfolio Management will own... ...in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (...RegulatoryPermanent employmentFull timeWork at officeWork from homeShift workModerna Therapeutics
Cambridge, MA3 days ago- ...through rigorous science and a collaborative, mission-driven culture. Primary Responsibilities The Director/Senior Director, Regulatory CMC (Chemistry, Manufacturing, and Controls) is a pivotal regulatory role responsible for developing and executing regulatory...RegulatoryRemote workFlexible hours
IMMUNEERING CORPORATION
New York, NYa month ago $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...RegulatoryFull timeContract workInternshipLocal areaRemote work2 days per weekAllogene Therapeutics
South San Francisco, CA12 days ago$121.6k - $194.5k
...and delivery of data products and AI use cases across Moderna's CMC organization. This role operates at the intersection of... ...in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens...RegulatoryPermanent employmentFull timeWork at officeWork from homeModerna Therapeutics
Norwood, MA3 days ago- ...Director, Regulatory CMC Join Acadia as the Director, Regulatory CMC and play a critical role in advancing innovative small molecule therapies from development through commercialization worldwide. In this leadership position, you will develop and execute global regulatory...RegulatoryWork at officeRemote workWorldwideNight shift
- ...Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description This is a position to lead and execute global CMC regulatory strategy and submissions, ensuring the delivery of high-quality CMC dossiers in full compliance with US & CA regulatory...RegulatoryFull timeWork at officeNight shift
