Global Regulatory CMC Lead for Cell Therapy
Bristol-Myers Squibb Company
Bristol Myers Squibb’s Global Regulatory Sciences - CMC team seeks an Associate Director to lead content development and review of CMC submissions across global markets. You will guide manufacturing change controls, support HA submissions, and coordinate with GPS/CTDO teams to ensure regulatory success. In this role, you will manage complex projects, provide strategic input on regulatory expectations, and interact with health authorities as part of cross-functional teams. #J-18808-Ljbffr
- ...Bristol Myers Squibb seeks a GRS-CMC Director to oversee multiple development and lifecycle management projects, guiding regulatory strategy in CMC to support global filings. You will lead cross-functional teams, mentor staff, and represent BMS in Health Authority meetings...Regulatory
- ...Made Scientific Made Scientific is a leading U.S.-based cell therapy contract development and... ...solutions. Backed by GC Corporation, a global leader in the pharmaceutical and biotechnology... ..., ensuring high-quality operations, regulatory compliance, and adherence to CGMP...RegulatoryFull timeContract workWork at officeLocal areaWeekend work
$239.08k - $289.71k
...Executive Director, Neuroscience Global Commercial StrategyPrinceton... ...the latest breakthroughs in cell therapy, this is work that... ...execution. The role will also lead strategies to optimize global... ...with Development, Medical, Regulatory, CMC, Commercial, and Strategy &...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workWorldwideFlexible hoursShift work- ...Kardigan is seeking a Senior Director, CMC Regulatory to lead CMC regulatory strategies and drive global submissions for late-stage assets. The role reports to Head of CMC Regulatory and collaborates with cross-functional teams across development and manufacturing in Princeton...Regulatory
$196.7k - $353.4k
...Translational Medicine Lead - Autoimmune. This individual... ..., pathogenic T- and B-cell biology, immune-cell... ...pathogenic and regulatory T-cell biology, B-cell... ...class immunomodulatory therapies.Experience with mRNA therapeutics... ...days, sabbatical, global recharge days, and a discretionary...RegulatoryPermanent employmentFull timeWork at officeWork from home$175k - $192.5k
Kyowa Kirin is a global specialty pharmaceutical company backed... ...generation of antibody, cell, and gene therapies, with particular emphasis... ...is responsible for leading cross-functional project management... ...clinical, nonclinical, CMC, regulatory, and commercialization activities...RegulatoryContract workSummer workWork at officeLocal areaWorldwide- ...About Freyr Freyr Inc. is a leading global Regulatory Solutions and Services company, supporting large, mid, and small-sized global Life Sciences... ...Regulatory Labeling function supporting Plasma-Derived Therapies (PDT). The role is responsible for providing regulatory...RegulatoryPermanent employmentFull timeRemote work
$210.9k - $379.2k
...strategic partners worldwide, contributing to global health initiatives.Moderna's commitment... ....Moderna is seeking a Global Medical Lead to lead medical affairs strategy across our... ...The role will interface extensively with regulatory, clinical, commercial, and external...RegulatoryPermanent employmentFull timeWork at officeWork from homeWorldwide$290k - $350k
...Executive Director, Global Medical Affairs Lead - Oncology Reports to: SVP, Head of Clinical Development and Medical Affairs Location:... ...affairs activities with the company's strategic objectives and regulatory requirements. The ideal candidate will have a strong...RegulatoryRemote work- ..., NJ, seeks an Associate Director of Process Development to lead cell therapy manufacturing from early-stage development to commercial production... ...processes, project leadership, and strong collaboration with clients to advance programs and regulatory filings. #J-18808-LjbffrRegulatory
$222k - $303k
...does every person who joins in. As a global biopharmaceutical company dedicated... ...We’re looking for a Senior Director, Regulatory Affairs CMC - Gene Therapy to help us expand what’s possible... ...Director will serve as the regulatory lead at the CMC sub team level and as an...RegulatoryFull timeLocal areaRemote workFlexible hours$190k - $210k
...Pharma is a dynamic, fast-growing global biopharmaceutical company... ...potentially best-in-class therapies to address unmet medical needs... ...Effectiveness, Medical Content Platform Lead is responsible for leading... ...across Medical Affairs, Regulatory Affairs, Market Access,...RegulatoryFull timeTemporary workLocal areaFlexible hours$294.48k - $386.51k
...Legend Biotech is a global biotechnology company dedicated... ...the next generation of cell therapy through a portfolio of... ...Myeloma Pipeline Lead as part of the Clinical... ...asset differentiation regulatory strategy lifecycle planning... ...Project Management CMC Commercial and Market Access...RegulatoryPermanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours$166.35k - $201.57k
...the latest breakthroughs in cell therapy, this is work that transforms... ...Professional Societies, leading interactions, and cultivating... ...required.Partners with the Global Medical Oncology Disease Area... ...with company policy, legal and regulatory requirements.Qualifications...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeRemote workFlexible hoursShift work- ...Myers Squibb seeks an Executive Director, Neuroscience Global Commercial Strategy in Princeton, NJ to lead the global brand strategy for KarXT. You will align... ...-functional teams across development, medical, regulatory, and commercial to shape an integrated launch plan...RegulatoryWorldwide
$139k - $142k
...oncology. Summit has multiple global Phase 3 clinical studies, including:Non-small Cell Lung Cancer (NSCLC)... ...Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China... ...-support analyses for the CMC/Supply Chain team.Run and...Regulatory$150k - $258.75k
...Number: R-130620 We are searching for the best talent for a Global Strategic Programs Lead. This position will be located (onsite/hybrid) in... ...Management Performance Measurement Problem Solving Regulatory Environment Strategic Analysis Strategic Change...RegulatoryWork experience placementLocal areaImmediate startRemote workFlexible hours3 days per week- ...Kyowa Kirin North America is seeking a Veeva Vault Architect to lead architecture, design and delivery of Vault-based solutions across the organization. You will align Vault configurations with regulatory requirements and enterprise standards while collaborating with business...Regulatory
$150.5k - $183.5k
Job SummaryThe Global Trial Leader (GTL) provides global, regional or complex local management... ...vendor proposals and other documents and lead initiatives as assigned by the function... ...finalization, Translations, EC and Regulatory submission, Site initiation etc.).Define...RegulatoryContract workLocal areaFlexible hours- ...Evolve Therapy Services is seeking a Director of Rehabilitation for an in-house Skilled Nursing Facility in Princeton, NJ. This role leads the therapy program, upholding company standards and regulatory requirements while guiding staff and coordinating with the facility...Regulatory
$193.63k - $254.14k
Legend Biotech is a global biotechnology company dedicated to treating... ...the next generation of cell therapy through a portfolio of... ...Biotech is seeking a Director, Regulatory CMC as part of the Regulatory... ...Responsibilities Develop, lead, and execute global CMC regulatory...RegulatoryPermanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours- ...SUN PHARMA in New Jersey seeks a Global Trial Leader to oversee global, regional or complex local clinical trials and lead the Clinical Trial Team as the operations contact... ...budgets, monitoring enrollment, ensuring regulatory compliance, and maintaining TMF/eTMF. #J-1...RegulatoryLocal area
$190k - $205k
...Pharma is a dynamic, fast-growing global biopharmaceutical company... ...potentially best-in-class therapies to address unmet medical needs... ...Medical Scientist will also lead execution of selected global... ...with internal SOPs and global regulatory requirementsWork closely with...RegulatoryFull timeTemporary workWork at officeLocal areaFlexible hours$203k - $242.56k
...oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC)... ...Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than... ...prior experience as lead attorney for drafting and...RegulatoryContract workFlexible hours- ...Made Scientific Made Scientific is a leading US-based cell therapy contract development and... ...spirit of a specialist CDMO with the global expertise and resources of GC Corporation... ...ensuring full compliance with GMP and regulatory requirements. The ideal candidate has...RegulatoryContract work
$189.7k - $237.1k
Position Summary Director, Regulatory CMC. Role can be based in San Diego, CA; San Francisco, CA; or Princeton, NJ. Hybrid model: work in office... ...development; 5 years in a management role. Knowledge of global regulatory CMC requirements/guidelines. Experience preparing/submitting...RegulatoryWork at officeWorldwide3 days per week$17.65 - $26.45 per hour
...care, surgery centers, imaging, lab, and therapy, you are part of a system designed to deliver... ...Required Responsibilities The Lead Phlebotomist is responsible for the... ...meeting the requirements with all OSHA and regulatory agencies with appropriate use and disposal...RegulatoryFull timeLocal areaImmediate startMonday to FridayShift work$220k - $240k
...Pharma is a dynamic, fast-growing global biopharmaceutical company... ...potentially best-in-class therapies to address unmet medical needs... ...an experienced and strategic regulatory affairs leader looking for an... ...opportunity. You will Lead the Global Labeling function...RegulatoryTemporary workWork at officeLocal areaWorldwideFlexible hours$148k - $188k
...Summit has multiple global Phase 3 clinical studies... ...: Non-small Cell Lung Cancer (NSCLC)... ...an investigational therapy not presently approved by any regulatory authority other than... ...Responsibilities Lead analytical method development... ...Affairs, and other CMC functions to deliver...RegulatoryContract workFlexible hours$190k - $228k
...field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3... .... Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical...RegulatoryFor contractorsRemote work
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