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- ...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
$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$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$250k - $272.02k
...Sr Director, Regulatory Affairs CMC *PC 1626 Locations Showing 1 location Baltimore, Maryland Baltimore, MD, USA +7 more locations Remote Clinical Full-Time Description Your Role: The role will lead the team of global CMC RA managers and as the...RegulatoryFull timeWork at officeLocal areaRemote workWorldwideMiltenyi-Biomedicine,-Inc.
Baltimore, MD50 minutes ago- 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
- 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
$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- ...defined by clinical or imaging features. For more information, visit Role The Associate Director/Director/Sr. Director, Regulatory CMC reports to the Vice President of Regulatory CMC and is responsible for managing the Company’s Regulatory CMC function to enable...RegulatoryFull timeContract workRemote workVisa sponsorshipWork visa
TG Therapeutics, Inc.
North Carolina2 days ago - 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
- 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
$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$272k - $340k
...individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You’ll Do: Vice President of CMC Regulatory will lead all aspects of CMC Regulatory. Reporting into the Senior Vice President of Regulatory, you will provide strategic and...RegulatoryFull timeLocal areaRemote workWork from homeFlexible hours3 days per weekKailera Therapeutics, Inc.
Waltham, MA2 days ago- ...seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight for API development and... ...manufacturing at Travere CDMOs. This role collaborates across Quality, Regulatory Affairs, Clinical and Supply Chain to align on risk and...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- 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
$166.4k - $249.6k
Job DescriptionGeneral Summary:The Chemistry Manufacturing Controls Associate Director executes multi-product global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and manages...RegulatoryFull timeSummer workRemote workFlexible hours2 days per weekVertex Pharmaceuticals
Boston, MA13 hours 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, MA4 days ago- 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
- ...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
Foster City, MI4 days ago - ...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
- ...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
$120k - $140k
...leading patent portfolio is available on the Intellectual Property page on Overview Iovance seeks a highly motivated Regulatory Affairs CMC Associate II. The successful candidate has experience planning and managing regulatory authority submissions. This role...RegulatoryFull timeWork at officeLocal areaRemote workWorldwide$177k - $278.08k
...role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery... ...as follows: Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval...RegulatoryMinimum wageLocal areaRemote workWorldwideTakeda
Boston, MA1 day ago$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- ...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
- ...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, NC4 days 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 hoursGILEAD Sciences
Foster City, MI1 day 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
$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
