Senior Toxicologist & Regulatory Lead (Nonclinical Safety)
BioSpace
Regeneron seeks a Senior Toxicologist to lead nonclinical development programs with guidance from a supervisor, applying GLP regulations and FDA/ICH guidelines to independently design, conduct, analyze, and report regulatory toxicology and exploratory studies in rodent and non-rodent models. The role involves primary authorship of regulatory documentation, collaboration with cross‑functional teams, budget and timeline oversight at CROs, and staying current with safety science to support IND/NDA #J-18808-Ljbffr BioSpace
- ...Pharmaceuticals, Inc (USA) is seeking a Senior Toxicologist to lead nonclinical development programs with guidance... ...of GLP regulations and FDA/ICH safety guidelines, with primary responsibility... ..., interpreting, and reporting regulatory toxicology studies and related pharmacology...SeniorRegulatory
- 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...SeniorRegulatory
- Regeneron Pharmaceuticals, Inc. in New York seeks a Senior Toxicologist to lead nonclinical development programs with guidance from a supervisor. The... ...to independently design, conduct, and interpret regulatory toxicology studies in rodent and non-rodent models, including...SeniorRegulatory
- ...Innovative Medicine is recruiting a Distinguished Scientist, Nonclinical Safety Leader to guide toxicology across discovery and... ...requires deep experience in nonclinical safety and regulatory collaborations. You will lead PSTS project teams, mentor scientists, and...SeniorRegulatory
- ...Cambridge, MA, seeks a Program Toxicologist to provide scientific and strategic leadership for nonclinical studies across discovery to... ...The role partners with program leads and cross-functional teams to... ...scientific rigor with regulatory collaboration. #J-18808-Ljbffr...SeniorRegulatory
- Novartis in Cambridge, MA seeks a senior Nonclinical Safety leader to drive global safety programs across modalities, ensuring regulatory-compliant strategies that support clinical entry... ...teams and Health Authorities. You will lead safety strategy, author IND/NDA sections...SeniorRegulatory
- Novartis Group of Companies in Cambridge, MA, seeks a senior leader to provide global, end-to-end nonclinical safety leadership across oncology modalities, ensuring robust, regulatory-focused safety strategies for clinical trial initiation and registration. This hybrid...SeniorRegulatoryRelocation package
- Sanofi in Cambridge, MA seeks a senior toxicologist to lead nonclinical safety programs across drug candidates. You will design safety strategies, oversee... ...and collaborate with global project teams to ensure regulatory readiness and high scientific standards. The role requires...SeniorRegulatory
$227.6k - $341.4k
...are looking to recruit a talented Senior Project Toxicologist who has prior experience of late-stage... ...and global marketing into our Regulatory Toxicology and Safety Pharmacology team. In this role you... ...cross-functional partnerships to lead with confidence and shape studies...SeniorRegulatoryHourly payTemporary workWork at officeFlexible hours3 days per week- Jobtailor is seeking a Pharmacovigilance Lead in Cambridge, MA to manage signal detection, safety reporting, and regulatory interactions. You will finalize PSURs/DSURs and mentor a safety team, collaborating with Clinical Development and Regulatory groups. The role requires...SeniorRegulatory
$128.6k - $210k
...The Senior Toxicologist utilizes their scientific expertise and regulatory experience to lead nonclinical development programs with guidance from her/his direct supervisor working effectively... ...and FDA/EMEA/ICH nonclinical safety guidelines to independently lead the design...SeniorRegulatoryFull timeContract work- Senior Toxicologist The Senior Toxicologist utilizes their scientific expertise and regulatory experience to lead nonclinical development programs with guidance from their direct supervisor working... ...and FDA/EMEA/ICH nonclinical safety guidelines to independently lead the...SeniorRegulatoryContract work
- ...Cambridge, MA is seeking a Program Toxicologist to provide scientific and strategic leadership for nonclinical studies across the pipeline.... ...collaborates with program leads and subject-matter experts to... ...ensure risk assessments and regulatory submissions support INDs. #J...Regulatory
$174k - $184.95k
...subsidiary of Bayer AG, is a leading engineered cell... ...areas. The Program Toxicologist will be expected to take... ...leadership for nonclinical studies in support of... ...study design Identify safety-related knowledge gaps... ...report sections Author regulatory submissions,...RegulatoryLocal areaWorldwide- ...Digital Health is looking for a skilled toxicologist to join our Preclinical Safety group in Cambridge, MA. You will oversee the nonclinical safety program, engage with project... ...writing skills are essential as well as experience in regulatory submissions. #J-18808-LjbffrSeniorRegulatory
$179k - $236k
Reporting to the Chief Scientific Officer, this role leads DMPK and bioanalytical strategy across nonclinical and clinical programs, operating as a hands-on... ...external stakeholders Author nonclinical sections of regulatory filings (e.g., IND) and briefing documents;...SeniorRegulatory- ...the next 12 months is to advance our lead in vivo development candidate, EDIT-... ...Your Impact: As the Senior Director, Program Team Lead you will... ...dependencies, and timelines across Nonclinical, CMC, Quality, Regulatory, and Development Responsible for...SeniorRegulatoryWork at officeFlexible hours
$119.7k - $222.3k
...Toxicology line function of Preclinical Safety (PCS). Key areas of responsibility or oversight... ...with SEND (Standard for Exchange of Nonclinical Data) packages to provide support for... ...Experience working in GLP setting, and general regulatory compliance and animal welfare knowledge...RegulatoryPermanent employment- Judo Bio seeks a Senior Scientist to lead bioanalytical assay development and biomarker strategy in support of siRNA discovery and nonclinical programs. You will develop LC-MS/MS methods for oligonucleotides... ..., Pharmacology, Toxicology, and Regulatory to ensure regulatory-ready data...SeniorRegulatory
- Parabilis Medicines is seeking an Associate Director, Regulatory Affairs to lead regulatory strategy and execution across the product lifecycle in Cambridge, MA. This role focuses on advancing programs through optimized regulatory plans, with emphasis on NDA/BLA submissions...SeniorRegulatory
- ...compliance, and strategic oversight. In this hybrid role, you will mentor staff, develop process guides, and resolve complex policy questions, balancing regulatory requirements with operational needs across departments. #J-18808-Ljbffr Harvard Faculty of Arts and SciencesSeniorRegulatory
- Biogen is seeking a Senior Director, Immunology Early Development Strategy & External Innovation to lead strategic initiatives bridging discovery and early development across... ...programs, and ensure compliance with regulatory and quality standards #J-18808-Ljbffr BiogenSeniorRegulatory
- Initial Therapeutics, Inc. is looking for a Senior Advisor in Manufacturing Science and Technology to manage external manufacturing activities... ..., and ensuring timely delivery of materials while authoring regulatory documents. #J-18808-Ljbffr Initial Therapeutics, Inc.SeniorRegulatory
$157k - $173k
...has demonstrated encouraging safety and clinical activity... ...Position Summary: The Senior Manager, Regulatory Affairs will support the development... ...strategies across nonclinical, clinical, CMC, and device... ...May serve as regulatory lead for selected routine agency...SeniorRegulatoryLocal area- A biotechnology company in Cambridge, MA is looking for a Senior Director of Biostatistics to lead statistical activities for clinical programs, provide input during regulatory submissions, and mentor junior statisticians. This role demands expertise in statistical analysis...SeniorRegulatory
$184.54k - $276.81k
...Oncology Targeted Delivery (OTD) Safety team plays a critical role in... ...motivated Director, Project Toxicologist to join our OTD Safety group.... ...R&D, bridging discovery and regulatory toxicology. You will develop... ..., MD What You’ll Do Lead toxicology strategies: Design...RegulatoryHourly payTemporary workWork at officeFlexible hours3 days per week- Relay Therapeutics is recruiting for an Associate Director/Director, CMC Regulatory in Cambridge, MA. You will lead regulatory CMC strategies for small molecule programs, develop global submission plans, and coordinate cross-functional teams to ensure regulatory success...SeniorRegulatory
- Treeline Biosciences is seeking an Associate Director / Director, Medical Writing in Oncology to author and coordinate high-quality regulatory and clinical documents across the product lifecycle. You will own documents end-to-end and coordinate with Regulatory, Clinical...SeniorRegulatory
- ...Incorporated is seeking a Principal Statistical Programmer to lead and mentor a team, delegate tasks, and provide expert SAS support... ..., support eCTD submissions (ISS/ISE), and uphold Vertex and regulatory standards, with eligibility for remote/hybrid work options. #J...SeniorRegulatoryRemote job
- ...Job Description Job Description Scientist/Senior Scientist, Biology Lead – Kidney Experience About the Role We are seeking a highly motivated... ...closely with chemistry, delivery, translational, regulatory, and external teams · Help define scientific strategy...SeniorRegulatory
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