CMC Regulatory Lead — Cell Therapy & Aging Biotech
Retro Biosciences
Retro Biosciences in Redwood City seeks an experienced CMC Regulatory Lead to oversee the regulatory strategy and operations. You will manage global CMC regulatory activities for both cell therapies and small molecules, collaborating across teams and leading health authority communications. The ideal candidate will have over 7 years of experience, particularly in cell therapy, and will thrive in a mission-driven environment focused on longevity research. #J-18808-Ljbffr Retro Biosciences
- ...Retro develops therapies for diseases driven... ...the biology of aging. We focus on... ...to rejuvenate cell and tissue function... ...member of our Regulatory team who will... ...and Controls (CMC) regulatory work... ...and play a leading role in building... ...approaches in a growing biotech organization....Regulatory
- ...is seeking an experienced Regulatory professional to own the strategy and operations for CMC regulatory work across our aging biology programs. This onsite... ...and amendments. You will lead cross-functional teams,... ...CMC processes in a growing biotech focused on longevity research...Regulatory
- ...Director, Lirentelimab CMC Team Leader... ...of immune effector cells involved in allergic... ...developing innovative therapies that transform patients... ...business, quality, regulatory representatives who... .... Your Role: Lead a cross-functional... ...or ethnic origin, age, religion or belief...Regulatory
- ...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...Regulatory
- ...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....RegulatoryWork at office3 days per week
$100k - $160k
...traditional allogeneic stem cell transplant has... ...prove fatal or lead to serious... ...next-generation cell therapies with the goal of providing... ...to join our CMC organization and provide... ...into clear, regulatory-defensible conclusions... ...QC environment in biotech/pharma....RegulatoryFull timeLocal areaRemote work$201k - $251k
...developing novel targeted therapies for patients with... ...:The Director of Regulatory Affairs (US Filing Lead) is accountable for... ...Clinical, Biostatistics, CMC, Quality,... ...the pharmaceutical/biotech industry or relevant... ...national origin/ancestry, age, disability, marital...RegulatoryFull timeWork experience placementLocal area$244k - $305k
...company developing novel targeted therapies for patients with RAS-... ...Senior Director, Molecule Global Regulatory Lead will develop and execute... ...Development, Biometrics, and CMC to deliver high-quality global... ...expression, national origin/ancestry, age, disability, marital status,...RegulatoryFull timeLocal area- A leading clinical-stage biotech company is seeking a Director/Senior Director for the Lirentelimab CMC team in Redwood City, CA. This role involves leading a cross-functional team... ...leadership capabilities, and experience in regulatory submissions. The position offers a...Regulatory
- ...medicines, molecular and pharmacologic therapies, cell and immune-based interventions, and... ..., in close collaboration with leading academic and biotech partners across the U.S. and abroad... ...Experience contributing to IND-enabling or regulatory-facing studies, even indirectly...RegulatoryContract work
$130k - $179k
...Manager, Regulatory Affairs Redwood City, CA JOIN US! Adicet Bio... ...allogeneic gamma delta T cell therapies for autoimmune diseases and cancer... ...for managing the global CMC regulatory implementation of... ...national origin, genetics, disability, age, or veteran status....RegulatoryFull timeTemporary workWork at officeFlexible hours3 days per week$194k - $199k
...clinical studies, including: Regulatory Studies Non-small Cell Lung Cancer (NSCLC) HARMONi... ...is an investigational therapy not presently approved by regulatory... ..., Regulatory Affairs, CMC is responsible for... ..., gender, national origin, age, sexual orientation, marital...RegulatoryWork at office- Enigma Search is seeking a Biologics CMC Project Manager for a stealth stage biopharmaceutical client. You will lead CMC development from PCC nomination through IND submission... ...proven ability to drive CDMO partnerships, regulatory compliance, and manufacturing readiness for...Regulatory
$199k - $274k
...allogeneic gamma delta T cell therapies for autoimmune... ...responsible for building and leading the QA Operations team... ...Process Development, Regulatory, Program Management,... ...operations to support CMC operations and clinical... ...genetics, disability, age, or veteran status. #J...RegulatoryFull timeTemporary workFor contractorsWork experience placementWork at officeFlexible hours3 days per week- Director, CMC Project Management (Biologics) About Our Client Our... ...acceleration of life-changing therapies to clinical trials.... ...multidisciplinary CMC teams, including cell line development, upstream and... ...manufacturing, quality control, regulatory filing, and supply chain...RegulatoryContract work
$294k - $367k
...developing novel targeted therapies for patients with RAS-... ...President, Global CMC Regulatory, reporting to SVP of Pharmaceutical... ...(PDM) Regulatory, to lead our global chemistry,... ...of experience in the biotech/pharmaceutical... ...origin/ancestry, age, disability, marital status...RegulatoryFull timeLocal area$157.59k - $203.94k
...working relentlessly to develop therapies that help improve lives and... ...Senior Manager, CMC Regulatory Affairs - Combination Products... ...Combination Product and Device Lead for assigned device and combination... ...religion, national origin, sex, age, sexual orientation, physical...RegulatoryFull timeFor contractorsLocal area$210.38k - $272.25k
...working relentlessly to develop therapies that help improve lives and... ...Job DescriptionThe Director, CMC Regulatory Affairs - Combination... ...responsible for setting and leading global CMC regulatory strategy... ...religion, national origin, sex, age, sexual orientation, physical...RegulatoryFull timeFor contractorsLocal area$132k - $166k
...developing novel targeted therapies for patients with RAS-addicted... ....Author and contribute to CMC documentation for regulatory submissions (e.g., INDs,... ...in the pharmaceutical/biotech industry settings.Experience... ...national origin/ancestry, age, disability, marital status...RegulatoryFull timeLocal area$175k - $225k
...Director, Quality Assurance - CMC Operations... ...Johnson company Janssen Biotech, Inc., is the first and... ...pediatric patients 12 years of age or older and is in... ...will be responsible for leading and managing QA activities... ...and guidance regarding regulatory requirements, and GMP...RegulatoryFull timeTemporary workWork at officeFlexible hours$250k - $300k
...CARegulatory Affairs - Regulatory Affairs /Regular,... ...allogeneic stem cell transplant has... ...can prove fatal or lead to serious conditions... ...-generation cell therapies with the goal of... ...global expansion, CMC Regulatory and other... ...commercial-stage biotech environment.Reporting...RegulatoryFull timeLocal areaImmediate startRemote work- Rezolute, Inc. is seeking a Sr Director of Regulatory Affairs to lead late-stage regulatory strategies for biologics, with a focus on US FDA interactions... ...demands strategic vision and execution in a fast-paced biotech environment. Ideal candidate has 15+ years in regulatory...Regulatory
- ...Job Description Retro develops therapies for diseases driven by the biology of aging. We focus on cellular reprogramming... ...studies for our iPSC-derived cell therapy products, including microglia... ..., specification-setting, regulatory submissions, and long-term control...RegulatoryFlexible hours
$119k - $149k
...developing novel targeted therapies for patients with RAS-addicted... ...Author and contribute to CMC documentation for regulatory submissions (e.g., INDs,... ...in the pharmaceutical/biotech industry settings. Academic... ...national origin/ancestry, age, disability, marital status...RegulatoryFull timeInternshipLocal area$170k - $198k
...attempted to protect humankind.*LEAD WITH HEART: Everyone leads at... ...as Associate Director, CMC Statistician. The position will... ...Development, MSAT, Stability, Quality, Regulatory Affairs, Manufacturing, and... ...CMC statistics experience in biotech/pharma, excellent technical writing...RegulatoryRemote work- ...working relentlessly to develop therapies that help improve lives and to... ....Job DescriptionFUNCTION: Regulatory Affairs Business Operations -... ...reports, with responsibility to lead other people managers. You will... ...religion, national origin, sex, age, sexual orientation, physical...RegulatoryFull timeFor contractorsLocal areaWorldwide
$144k - $180k
...molecular diagnostic tests. As a Lead Biostatistician, you will... ...interpretation of clinical trials for regulatory submissions to support our... ...Natera™ is a global leader in cell‑free DNA (cfDNA) testing,... ...orientation, national origin, genetics, age, veteran status, disability or...RegulatoryImmediate startWorldwide- ...Assurance Operations to build and lead the QA Operations team supporting CMC activities across clinical... ...commercialization of gamma delta T cell therapies. The role requires extensive cGMP... ...collaboration with Manufacturing, Regulatory, and QA Systems to ensure quality...Regulatory
- Adicet Bio, Inc. in Redwood City, CA, seeks a Director of Quality Assurance Operations to build and lead the QA Ops team and ensure cGxP compliance across clinical and regulatory activities. The role partners with Manufacturing, Facilities, QC, Regulatory, and other...Regulatory
- Position: Executive Director, Regulatory Affairs CMC Location: Redwood City, CA Job Id: 270-1156 #... ...marketing of drug products. They will: Lead teams with regulatory CMC... ...status, race or national or ethnic origin, age, religion or belief, gender identity or...Regulatory
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