Regulatory Affairs Manager - CMC for Cell Therapy
Initial Therapeutics, Inc.
Adicet Bio, Inc. seeks a Manager, Regulatory Affairs to lead global CMC regulatory strategies for its cell therapy programs. You will manage submissions and coordinate with FDA and international agencies while collaborating with development, QA, and manufacturing teams. The ideal candidate will have extensive experience with FDA/ex-US submissions, strong scientific background, and the ability to drive timelines in a fast-paced setting. Onsite presence is required for collaboration across teams. #J-18808-Ljbffr Initial Therapeutics, Inc.
- ...Description Retro develops therapies for diseases... ...to rejuvenate cell and tissue function... ...new member of our Regulatory team who will own... ...Manufacturing, and Controls (CMC) regulatory work.... ...of the Regulatory Affairs team, you will... ...workstreams, manage multiple...Suggested
- ...Inc. is a clinical stage biotechnology company focusing on allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. The Manager, Regulatory Affairs will lead global CMC regulatory strategy and submissions to accelerate clinical and product development....SuggestedWork at office3 days per week
- Retro is seeking an experienced Regulatory professional to own the strategy and operations for CMC regulatory work across our aging biology programs. This onsite role in Redwood City reports to the Regulatory Affairs leader and will build out global CMC capabilities for...Suggested
- ...Inc. is a clinical stage biotechnology company developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. The Manager, Regulatory Affairs will lead global CMC regulatory strategies and submissions in early to late-stage development, supporting...Suggested
$250k - $300k
Menlo Park, CARegulatory Affairs - Regulatory Affairs /Regular,... ...traditional allogeneic stem cell transplant has been... ...next-generation cell therapies with the goal of... ...operations and lifecycle management, while also... ...indications, global expansion, CMC Regulatory and other...SuggestedFull timeLocal areaImmediate startRemote work$302.01k - $390.83k
...and cancer - working relentlessly to develop therapies that help improve lives and to ensure access... ...together.Job DescriptionJOB DESCRIPTIONLead CMC teams/ groups to support the CMC product and portfolio regulatory affairs goals and contribute to the development of global...Full timeFor contractorsLocal area$157.59k - $203.94k
...hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these... ..., together.Job DescriptionJOB DESCRIPTIONThe Senior Manager, CMC Regulatory Affairs - Combination Products and Device is responsible for supporting...Full timeFor contractorsLocal area$130k - $179k
...Manager, Regulatory Affairs Redwood City, CA JOIN US! Adicet Bio, Inc. is a clinical stage biotechnology... ...developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer.... ...responsible for managing the global CMC regulatory implementation of assigned...Full timeTemporary workWork at officeFlexible hours3 days per week- ...lead the QA Operations team supporting CMC activities across clinical development and commercialization of gamma delta T cell therapies. The role requires extensive cGMP experience... ..., and collaboration with Manufacturing, Regulatory, and QA Systems to ensure quality across...
$244k - $305k
...developing novel targeted therapies for patients with RAS-... ...for non-small cell lung cancer (NSCLC). The... ...to Commercial, Medical Affairs, Market Access, Patient... ...governance controls.Develop, manage, and conduct... ...and evolving legal or regulatory requirements.The successful...Full timeLocal areaShift work- ...A biopharmaceutical company in Redwood City is seeking an Executive Director of Regulatory Affairs CMC to lead the regulatory strategy for drug products. The ideal candidate will have 15 years of regulatory CMC experience and a successful track record in preparing BLAs...
$211k - $264k
...company developing novel targeted therapies for patients with RAS-... ...Opportunity:The Director of Regulatory Affairs (US Filing Lead) is accountable... ...at RevMed. They will manage end-to-end execution of the... ...Regulatory, Clinical, Biostatistics, CMC, Quality, Translational...Full timeWork experience placementLocal area$244k - $305k
...developing novel targeted therapies for patients with RAS-... ..., Molecule Global Regulatory Lead will develop and... ...registration and lifecycle management. This leader will... ...Development, Biometrics, and CMC to deliver high-... ...+ years of regulatory affairs experience within the...Full timeLocal area- ...delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are... ...recognize and attack diverse cancer cells in each patient. The Iovance TIL platform... ...patients with cancer. Overview The Manager, Regulatory Affairs, represents Regulatory Affairs on cross...Work at officeRemote work
$166k - $195k
...demonstrating integrity, accountability, equality and clarity across communications and decision making.Summary:The Sr. Project Manager, Regulatory CMC will serve as a key contributor to the company’s project management, regulatory and CMC functions. Reporting to the Vice...3 days per week$180k - $210.5k
...develops and executes multi-product global regulatory CMC strategies for investigational products... ...filing of regulatory CMC submissions. Manages interactions with Health Authorities... ...Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices...- ...developing transformative therapies for patients living... ...Reporting to the Chief Regulatory Officer, the Sr Director of Regulatory Affairs will join the regulatory... ...strong understanding of CMC considerations for... ...project teams and Company management. Ensure alignment of regulatory...Local area
- ...Position: Executive Director, Regulatory Affairs CMC Location: Redwood City, CA Job Id: 270-1156 # of Openings: 1 Allakos Inc. is a dynamic... ...a monoclonal antibody or therapeutic protein. 5+ years of management experience preferred. The salary is competitive and commensurate...
$280k - $310k
...and have fun, seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will provide... ...topics, and effectively oversees change controlsBuilds and manages relationships through active partnering with key internal and...Local area$186k - $233k
...oncology company developing novel targeted therapies for patients with RAS-addicted... ...:The Associate Director, Global Regulatory Affairs Project Management is an integral part of the global Regulatory... ..., Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and...Full timeWork at officeLocal area$186k - $233k
...company developing novel targeted therapies for patients with RAS-... ...trends, enforcement actions, and regulatory developments.Serve as a... ...supporting Commercial and Medical Affairs organizations in a... ...communication, and stakeholder management skills.Preferred Skills:Certified...Full timeLocal area$164k - $205k
...oncology company developing novel targeted therapies for patients with RAS-addicted cancers.... ...to play a critical role as Senior Manager, IS Quality and Compliance within the Information... ...to maintain inspection readiness and regulatory compliance. This position reports to the...Full timeLocal area- ...on developing novel targeted therapies to inhibit frontier targets... ...interest, third-party risk management, anti-bribery and corruption... ...functions. Support Quality and Regulatory departments with compliance... ..., Marketing, Medical Affairs, Market Access, and Regulatory...Full timeWork at officeLocal areaRemote workRelocation
$265k - $331k
...company developing novel targeted therapies for patients with RAS-... ...ensure adherence to applicable regulatory requirements, industry... ...quality systems, compliance risk management, supplier oversight and... ...Quality Assurance, Regulatory Affairs, Clinical Development, Life...Full timeLocal area$150k - $189k
...company developing novel targeted therapies for patients with RAS-addicted cancers... ...pathway.The Opportunity:The Senior Manager, Compliance Monitoring & Data... ...activities across Commercial, Medical Affairs, Clinical Development, Regulatory, Market Access, Patient Services, Finance...Full timeLocal area$194k - $199k
...Therapeutics, Inc. is seeking an experienced Associate Director of Regulatory Affairs, CMC to coordinate global regulatory filings. This role requires... ...of FDA and EU regulations. The position focuses on managing CMC regulatory aspects and preparing submissions. The salary...Work at office$153k - $178k
...hands-on and detail-oriented Lab Compliance Manager to join our Global Analytical... ...within Global Analytical support Vaxcyte's CMC programs by performing method development... ...characterization testing activities that enable regulatory filings. This role will serve as the primary...Work experience placement$186k - $233k
...oncology company developing novel targeted therapies for patients with RAS-addicted cancers.... ...and experience with clinical study management, International Conference on Harmonization... ..., Good Clinical Practices (GCP) and regulatory requirements.SME for Clinical Operations...Full timeWork at officeLocal area$302.01k - $390.83k
...working relentlessly to develop therapies that help improve lives and... ...Head of Precision Medicine Regulatory is responsible for defining... ..., Global Regulatory Affairs Oncology and Precision Medicine... ...validation of IVDs (e.g., Study Management, Clinical, Biomarkers) and presents...Full timeFor contractorsWork at officeLocal areaFlexible hours$183k - $194k
...develops and executes multi-product global regulatory CMC strategies for investigational products... ...filing of regulatory CMC submissions. Manages interactions with Health Authorities... ...Essential Functions:Represent Regulatory Affairs in various internal cross-functional...RelocationRelocation package
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