Lead Program Toxicologist - Cell Therapy & Regulatory
BlueRock Therapeutics LP
BlueRock Therapeutics LP in Cambridge, MA is seeking a Program Toxicologist to provide scientific and strategic leadership for nonclinical studies across the pipeline. The role collaborates with program leads and subject-matter experts to advance development. The position requires a Ph.D. with at least 4 years of toxicology industry experience, experience partnering with CROs, and GLP compliance. Travel to CROs as needed; ensure risk assessments and regulatory submissions support INDs. #J-18808-Ljbffr BlueRock Therapeutics LP
$174k - $184.95k
...operated subsidiary of Bayer AG, is a leading engineered cell therapy company pioneering a new... ...ourselves. Description of Position The Program Toxicologist will be expected to take on a highly... ...IB/Annual report sections Author regulatory submissions, including nonclinical...RegulatoryLocal areaWorldwideShift work- ...author relevant IB/Annual Report sections as needed Author regulatory submissions, including nonclinical IND sections, and... ...dissemination Stay current on the evolving regulatory landscape of cell-based therapies Requirements Ph.D. in relevant field Minimum of 4 years...RegulatoryLocal area
- Arbor Biotechnologies in Cambridge, MA is seeking a Director of Regulatory Affairs to lead regulatory strategy and execution across our preclinical and early clinical programs. Reporting to the Chief Medical Officer, you will serve as the Global Regulatory Lead on program...Regulatory
- Agios Pharmaceuticals in Cambridge, MA, seeks a visionary Program Leader to own the asset's strategy from late-stage development through regulatory approval, launch, and lifecycle management. You will lead a cross-functional team across Regulatory, Clinical Development,...Regulatory
- ...Cambridge, MA, is seeking a Senior Scientist to advance our lead iPSC-derived thymic cell therapy program. You will design and execute proof-of-concept and... ...collaborate with Research, Process Development and Regulatory teams to generate data informing #J-18808-Ljbffr...Regulatory
- CRISPR Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs CMC to lead regulatory CMC efforts for a portfolio of gene-based medicines. You will collaborate with cross-functional teams and partners to devise innovative regulatory strategies while coordinating...RegulatoryContract workWorldwide
$178.5k - $257.83k
Job Title: Lead, US Hematology Pipeline CommercializationLocation... ...of transformative therapies for patients affected... ...(wAIHA) and sickle cell disease. This role will... ...among clinical, regulatory, medical, access, and commercial... ...and wellness programs and at least 14 weeks’...RegulatoryFull time- Regeneron seeks a Senior Toxicologist to lead nonclinical development programs with guidance from a supervisor, applying GLP regulations and FDA/ICH guidelines... ...independently design, conduct, analyze, and report regulatory toxicology and exploratory studies in rodent and...Regulatory
$232.5k - $335.83k
Job Title: Global Brand Lead, Transplant (Solid... ...areas: Hematopoietic Stem Cell Transplantation (HSCT)... ...anti-thymocyte globulin therapy, alongside a promising... ...Corporate Affairs, Digital, Regulatory, and regional... ...prevention and wellness programs and at least 14 weeks’...RegulatoryFull timeLocal area- Regeneron is seeking a Senior Toxicologist to lead nonclinical development programs with regulatory oversight and cross‑functional collaboration. The role requires deep GLP and regulatory expertise to design, conduct, and report studies in rodent and non‑rodent models while...Regulatory
- Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Toxicologist to lead nonclinical development programs with guidance from their supervisor, collaborating... ...designing, conducting, interpreting, and reporting regulatory toxicology studies and related pharmacology work in...Regulatory
$195k - $330k
...building an industry-leading pipeline of oral small... ...convenient, highly effective therapies for patients with... ...Medicine Program Lead on cross-functional... ...technology platforms (e.g., cell-based assays, molecular... ...and/or manuscripts and regulatory documents (e.g. IND, IB...Regulatory- ...subsidiary in Cambridge, MA, seeks a Program Toxicologist to provide scientific and strategic leadership... .... The role partners with program leads and cross-functional teams to design,... ...combines scientific rigor with regulatory collaboration. #J-18808-Ljbffr BlueRock...Regulatory
- Voisin Consulting SARL is seeking a Senior Director of US Regulatory Strategy in Boston to lead regulatory guidance for biotech and pharmaceutical... ...BLA submissions, with a focus on complex biologics and therapies, emphasizing strong client relationships and business development...Regulatory
$212k - $333.19k
...Join us as a Senior Director, Global Program Lead- Neuroscience in our Cambridge, MA office... ...to simultaneously driving regulatory approval as well as launch and global... ...molecules or novel modalities such as Cell Therapy or Gene Therapy, large scale programs...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote work- Vertex Pharmaceuticals Incorporated is seeking an Executive Director, Regulatory Strategy to lead global regulatory strategies for Type 1 Diabetes programs. You will supervise a team of regulatory professionals and shape cohesive regulatory plans across development and...Regulatory
- ...leader to design and oversee nonclinical programs across discovery and development. You... ...and preparing risk assessments and regulatory documents. You will manage CRO relationships... ...with external experts to advance cell-based therapies, with a focus on regulatory submissions...Regulatory
- ...document owner where applicable.Lead investigations and provide... ...protocols.May participate in regulatory inspections and/or the implementation... ...with Human Error Prevention Programs (HEPP).Basic laboratory skills... ...working with mammalian cell cultureExperience working in an...RegulatoryWork at officeWeekend workAfternoon shift
$238k - $374k
...biotech and the resources of a leading pharmaceutical company. It is... ....Objective:As AIRx Biologics Program Lead, you will own the end-to... ...display, hybridoma, single B cell), lead optimization,... ...strong business acumen including regulatory (BLA/MAA pathway) and commercial...RegulatoryMinimum wageTemporary workLocal areaRemote work$310k - $340k
...revolutionize the development of small molecule therapies. We are excited about the potential of our lead program, RAP-219. Our first indication targets focal epilepsy... ...program teams (Discovery, Toxicology, CMC, Regulatory, Clinical, Biostatistics, New Product Planning)...RegulatoryFull timeWork at officeLocal areaImmediate start$229.56k - $344.35k
...for a visionary and strategic Program Leader to serve as the single... ...clinical development through regulatory approval, global launch, and... ...the Program Leader, you will lead the Program Team, aligning a... ...designed to deliver transformative therapies to patients with rare...RegulatoryTemporary workWork at officeFlexible hours3 days per week$206k - $257.5k
...building a robust portfolio of programs across muscle, central... ...2023, we launched our fourth therapy and the first ever gene therapy... ...Strategy and Field, the MSL Team Lead is responsible for the... ...complying with industry and regulatory compliance guidelines; ability...RegulatoryFull time$177k - $278.08k
...innovation and delivers transformative therapies to patients. By focusing R&D efforts on... ...worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the... ...submissions for high-impact oncology programs.How you will contribute:Oversee as well...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$136.4k - $253.2k
...Analytical Data Science is recognized as a leading hub for top industry talent, operating as an agile workforce to deliver regulatory commitments across the portfolio. We... ...exploratory analyses, and align statistical programming practices across both early- and late-stage...RegulatoryFull timeLocal area$98.5k - $109.1k
...principles and practices of cell processing and experience as... ...all backgrounds, and design programs to promote public health particularly... ...with all requirements of regulatory and accreditation agencies to... ...and compliance audits Leading and facilitating various quality...RegulatoryFull timeFlexible hoursShift workWeekend work$120 - $170 per hour
Associate Director, Clinical Program Quality Leader Base pay range... ...Development (R&D), Plasma Derived Therapy (PDT), Vaccines Business Unit... ...mitigations are in place. Leads the clinical pre-approval... ...potential or confirmed violations to regulatory authorities. Lead GCP health...RegulatoryTemporary workFor contractorsWork at officeImmediate startNight shift2 days per week$144.06k - $205.8k
...patients. We provide transformative therapies in disease areas that include... ...our research and development programs, we are pioneering new... ...and operational readiness. The Lead, Access Marketing, IZERVAY is... ...and applicable legal, regulatory, privacy, and promotional requirementsJob...RegulatoryWork at officeRemote workWork from homeWorldwide$136.86k - $195.51k
...patients. We provide transformative therapies in disease areas that include... ...our research and development programs, we are pioneering new... ...tangible impact.Purpose & Scope The Lead, Upstream Marketing position... ..., Market Access, Legal, Regulatory, and Compliance to deliver...RegulatoryWork at officeRemote workWork from homeWorldwide- ...characterization, and release assays for late-stage cell therapy manufacturing. You will collaborate... ...to ensure assays meet timelines and regulatory requirements, while contributing to the... ...transfer of analytical methods across programs. #J-18808-Ljbffr Aurion Biotech Inc.Regulatory
- VP, Program Management - Permanent - Massachusetts, USCan you unite clinical, regulatory, CMC, medical affairs, and commercial teams behind a... ...a transformational oncology therapy?Proclinical is seeking a Vice... ...of Program Management to lead the strategic direction and...RegulatoryPermanent employment
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