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
- 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
$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...SeniorRegulatoryContract 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
- ...recruitment partner, is seeking a Senior Scientist in Toxicology to shape the preclinical safety strategy for oligonucleotide... ...influence discovery, development, and regulatory decisions while collaborating... ...teams. The role requires leading GLP/non-GLP toxicology studies,...SeniorRegulatory
$100k - $130k
...Boston, Massachusetts is seeking a Principal Specialist of Regulatory Affairs & Compliance. This role demands expertise in... ...oversight to ensure product integrity and consumer safety. The successful candidate will lead cross-functional teams and manage compliance programs...SeniorRegulatory$138.39k - $207.59k
...to role: Are you ready to lead the systems that keep clinical... ...supplied, blinded, and on time? As Senior Manager, RTSM Lead, you will... ...data integrity and patient safety while shortening study timelines... ...and standards in line with regulatory requirements; drive the implementation...SeniorRegulatoryHourly payTemporary workFlexible hours- Boston Medical Center is seeking a Senior Risk Management Specialist to lead efforts in risk management, ensuring patient safety and regulatory compliance. This hybrid role mainly operates onsite and involves collaboration with various departments to mitigate malpractice...SeniorRegulatory
$212k - $333.19k
...and the resources of a leading pharmaceutical... ...carries real cost, and the safety call is the one that... ...sends it forward. As Nonclinical Safety Lead, you own... ...with a hands-on project toxicologist function in a unit... ...the competitive and regulatory landscape to inform decisionsDeep...SeniorRegulatoryMinimum wageTemporary workLocal areaImmediate startRemote work- Boston University is seeking a Senior Specialist, Occupational Health & Safety to oversee comprehensive workplace safety programs across the BU Medical Campus and related facilities. This role focuses on regulatory compliance, training, and fostering a culture of safety...SeniorRegulatory
- ...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... ...skills are essential as well as experience in regulatory submissions. #J-18808-Ljbffr...SeniorRegulatory
$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... ...settingExperience working in GLP setting, and general regulatory compliance and animal welfare knowledge...RegulatoryPermanent employmentFull time$275k - $300k
Centessa Pharmaceuticals is seeking a Senior Director, Toxicology in Boston, MA, to lead the development of nonclinical safety strategies for CNS programs. This role involves... ...staff, and ensuring compliance with regulatory standards. Applicants should have a PhD and...SeniorRegulatoryFull time- ...devastating diseases. We have built a world-leading drug design engine comprising AI models... ...in vivo pharmacology, PK/PD, and safety assessments throughout our project portfolios... ...go/no-go decisions and support IND regulatory filings. Act as a vital bridge between...SeniorRegulatoryContract workWork at office3 days per week
- ...stage biopharmaceutical company based in Cambridge is seeking a nonclinical pharmacology leader to advance oncology programs from... ...program to development candidate nomination. The role includes leading strategy, designing studies, and collaborating with internal teams...Senior
- Responsibilities Lead the global occupational and environmental toxicology strategy across all business segments. Serve as the enterprise... ..., and clients. Serve as a technical representative during regulatory inspections, client audits, due diligence activities, and...SeniorRegulatory
- Alkermes is seeking a Senior Manager of Regulatory Affairs to guide regulatory strategies for new product development and clinical progression, reporting to the Head of Orexin Regulatory Strategy. The role focuses on strategic and tactical regulatory leadership within...SeniorRegulatory
- ...seeking a highly motivated Senior Scientist in... ...drive the pre ‑clinical safety strategy for the successful... ...as Study Director, leading toxicology study operations... ...as an SME related to nonclinical safety issues.... ...document sections for regulatory submissions. Qualifications...SeniorRegulatory
- Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...SeniorRegulatory
$193k - $210k
A pharmaceutical firm in Cambridge, MA seeks a Senior Regulatory Affairs Manager to lead the development and execution of regulatory strategies throughout the product lifecycle. Candidates should hold a PhD in health or life sciences, with 6+ years of relevant experience...SeniorRegulatory- Treeline in Watertown, MA is looking for a Senior Manager, Clinical Data Management who... ...with CROs, manage external vendors, and lead process optimization efforts. The ideal candidate... ...in oncology, and a solid grasp of regulatory guidelines. This role entails mentoring junior...SeniorRegulatory
- WSP USA is seeking a Senior Environmental Compliance Specialist / Environmental Scientist to join our Northeast Region, including New... ...programs and EMS-related support. The role requires 5+ years of regulatory experience, ISO 14001 knowledge, and travel up to 50%. Strong...SeniorRegulatory
- A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates...SeniorRegulatoryRemote job
$105k - $140k
About the RoleThe Senior/Lead Analyst, Private Credit Operations role will be responsible for supporting all operational activities within... ...compliance and trade execution processes.Stay abreast of regulatory requirements and understand investment guidelines across multiple...SeniorRegulatoryLocal areaRemote work$150k - $211k
...oversee biopharmaceutical processes. This pivotal role commands responsibility for technical oversight, lifecycle management, and regulatory support for drug substances. The ideal candidate will have a Ph.D. and extensive experience in upstream and downstream processes,...SeniorRegulatoryRemote job- ...sciences management firm, seeks a Viral Vector Analytics Group Lead for a 3‑month onsite contract in the greater Boston area. You will... ...for viral vectors, oversee assay development, and ensure regulatory‑compliant QC readiness, working with internal and external partners...SeniorRegulatoryContract work
- Pathology Senior Principal Research Scientist page is loaded##... ...(Boston)**Preclinical Safety Assessment (PSA) is a... ...conduct of comprehensive nonclinical safety programs for the evaluation... ...pathology and regulatory toxicity studies from lead identification/optimization...SeniorRegulatoryContract workSummer workFlexible hours
- ...ensuring accuracy and timely submissions. Collaboration with product and legal teams to address objections and monitor ISO/NCCI bureau changes is essential. The role emphasizes regulatory analysis, documentation, and process optimization. #J-18808-Ljbffr ERGO NEXT InsuranceSeniorRegulatoryWork at office
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