Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

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

Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Senior Toxicologist & Regulatory Lead (Nonclinical Safety) in Cambridge, MA vacancy
  •  ...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... 
    Senior
    Regulatory

    Regeneron Pharmaceuticals, Inc (USA)

    Cambridge, MA
    3 days ago
  • 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... 
    Senior
    Regulatory

    Regeneron

    Cambridge, MA
    3 days ago
  • 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... 
    Senior
    Regulatory

    Regeneron Pharmaceuticals, Inc

    Cambridge, MA
    2 days ago
  •  ...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... 
    Senior
    Regulatory

    Johnson & Johnson Innovative Medicine

    Cambridge, MA
    5 days ago
  •  ...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... 
    Senior
    Regulatory

    BlueRock Therapeutics

    Cambridge, MA
    2 days ago
  • 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... 
    Senior
    Regulatory

    Novartis

    Cambridge, MA
    5 days ago
  • 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... 
    Senior
    Regulatory
    Relocation package

    Novartis Group Companies

    Cambridge, MA
    1 day ago
  • 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... 
    Senior
    Regulatory

    BioSpace

    Cambridge, MA
    5 days ago
  • $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... 
    Senior
    Regulatory
    Hourly pay
    Temporary work
    Work at office
    Flexible hours
    3 days per week
    Boston, MA
    22 days ago
  • 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... 
    Senior
    Regulatory

    Jobtailor

    Cambridge, MA
    1 day ago
  • $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... 
    Senior
    Regulatory
    Full time
    Contract work

    Regeneron Pharmaceuticals, Inc.

    Cambridge, MA
    more than 2 months ago
  • 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... 
    Senior
    Regulatory
    Contract work

    Regeneron Pharmaceuticals, Inc (USA)

    Cambridge, MA
    3 days ago
  •  ...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

    BlueRock Therapeutics LP

    Cambridge, MA
    5 days ago
  • $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,... 
    Regulatory
    Local area
    Worldwide

    BlueRock Therapeutics

    Cambridge, MA
    2 days ago
  •  ...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-Ljbffr
    Senior
    Regulatory

    Mass Digital Health

    Cambridge, MA
    4 days ago
  • $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;... 
    Senior
    Regulatory

    Flagship Pioneering

    Cambridge, MA
    5 days ago
  •  ...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... 
    Senior
    Regulatory
    Work at office
    Flexible hours

    Editas Medicine

    Cambridge, MA
    24 days ago
  • $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... 
    Regulatory
    Permanent employment

    Novartis

    Cambridge, MA
    1 day ago
  • 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... 
    Senior
    Regulatory

    Judo Bio

    Cambridge, MA
    2 days ago
  • 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... 
    Senior
    Regulatory

    Parabilis Medicines

    Cambridge, MA
    2 days ago
  •  ...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 Sciences
    Senior
    Regulatory

    Harvard Faculty of Arts and Sciences

    Cambridge, MA
    3 days ago
  • 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 Biogen
    Senior
    Regulatory

    Biogen

    Cambridge, MA
    3 days ago
  • 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.
    Senior
    Regulatory

    Initial Therapeutics, Inc.

    Watertown, MA
    3 days ago
  • $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... 
    Senior
    Regulatory
    Local area

    Avalyn Pharma

    Boston, MA
    16 days ago
  • 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... 
    Senior
    Regulatory

    BioSpace

    Cambridge, MA
    4 days ago
  • $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... 
    Regulatory
    Hourly pay
    Temporary work
    Work at office
    Flexible hours
    3 days per week

    AstraZeneca

    Cambridge, MA
    1 day ago
  • 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... 
    Senior
    Regulatory

    Relay Therapeutics

    Cambridge, MA
    5 days ago
  • 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... 
    Senior
    Regulatory

    Treeline

    Watertown, MA
    2 days ago
  •  ...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... 
    Senior
    Regulatory
    Remote job

    Vertex Pharmaceuticals Incorporated

    Boston, MA
    5 days ago
  •  ...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... 
    Senior
    Regulatory

    RAPTOR MEDICINES INC

    Allston, MA
    29 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Toxicologist & Regulatory Lead (Nonclinical Safety). Be the first to apply!