Senior Regulatory & Clinical Scientist - FDA-Regulated Studies
Socket.dev
Hims & Hers is seeking a Senior Scientist, Regulatory & Clinical Operations to lead coordination of FDA-regulated studies in our Central New Jersey on-site lab. The role sits at the intersection of bench science and clinical study execution, reporting to the Director of R&D. You will own end-to-end study execution with a CRO partner and ensure GCP compliance. The ideal candidate thrives in a fast-paced environment, translates regulatory rigor into practical decisions, and can operate #J-18808-Ljbffr Socket.dev
- Adlai Nortye seeks a Clinical Trial Manager with 3-8 years of experience to lead planning... ...guidelines and company SOPs. You will manage study timelines, budgets, CROs and cross-... ...study outcomes across Phase I-III, with regulatory submissions and inspection readiness in...SeniorRegulatory
- ...designers, engineers, scientists, digital innovators, program... ...is seeking a Senior Project Manager to lead... ...manages nuclear quality and regulatory expectations, and... ...integration, engineering studies, licensing support,... ...NQA-1 programs and/or regulated nuclear design environments...SeniorRegulatoryContract workFor subcontractorWork at officeLocal areaRemote workWorldwideFlexible hours
- ...seeking a highly motivated Sr. Clinical Trial Manager (SCTM) to be... ..., multicenter, late stage studies and may assume... ...ICH/GCP, Country specific regulatory guidelines, company goals,... ...In-depth understanding of FDA and EU regulations, ICH Guidelines and GCP requirements...SeniorRegulatory
$202k - $303k
The Senior Advisor: Market Regulation and Regulatory Service Agreement (RSA), serves as a strategic regulatory advisor and subject matter expert on market structure, market regulation, and Regulatory Services Agreement (RSA) matters. This role provides critical leadership...SeniorRegulatoryFull timeContract workTemporary workFor contractorsFor subcontractorWork at officeLocal areaImmediate start- L’Oréal is seeking a Senior Scientist I, Regulatory Affairs in Clark, New Jersey to guide product development through global regulatory standards... ...week, you’ll lead regulatory guidance, monitor evolving regulations, and collaborate with diverse teams to #J-18808-Ljbffr...SeniorRegulatory3 days per week
$117k - $184.2k
...Job Description The Senior Clinical Scientist provides scientific leadership for one or more clinical... ...partners with Clinical Directors, Study Managers, Clinical Operations,... ...Monitoring, Data Management, Statistics, and Regulatory colleagues to ensure the scientific...SeniorRegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$96.8k - $137k
...healthier future for all.We are looking for a Clinical Research Specialist for Dermal Clinical... ...testing and external clinical/case studies.Monitor the conduct of external clinical... ...Support, Research & Implementation, Safety, Regulatory, Legal, Marketing) to review concepts/...RegulatoryHourly payLocal areaRelocation- ...Senior Business Analyst - Global Patient Safety -... ...activities align with regulatory requirements and industry... ...such as EMA, FDA, and ICH guidelines.... ...functional teams including clinical research, regulatory affairs... ...of pharmacovigilance regulations and reporting requirements...SeniorRegulatory
- ...New Jersey, to optimize manufacturing processes and ensure regulatory compliance. The ideal candidate will have a Bachelor's... ...processes for efficiency, and maintaining compliance with FDA and EPA regulations. Proficiency in CAD software and process simulation tools...SeniorRegulatory
$90.2k - $135k
Senior Scientist II, Product Safety & Toxicology, L'Oréal Research... ...part of the SRCM (Safety, Regulatory, Claims, and Microbiology... ...ensuring they meet all global regulations. Technical Risk... ...in silico, in vitro, and clinical safety studies—is developed and executed...SeniorRegulatoryPermanent employmentFull timeSummer workWork at officeWork from homeFlexible hours$90.2k - $128.5k
..., hands-on, and data-driven Senior Scientist II - Cognitive Science within... ...execution of our cognitive study pipeline and the advanced statistical... ...with R&I, Legal, and Regulatory teams. Protocol Design:... ...evaluations conform to data privacy regulations (such as GDPR/US regulations...SeniorRegulatoryWork experience placementSummer workWork from homeFlexible hours2 days per week- ...Biosciences LLC in Piscataway, NJ, is seeking a Senior Environmental Health & Safety Manager.... ...and Chicago, ensuring compliance with regulatory requirements, and promoting a proactive... ...experience, strong knowledge of OSHA regulations, and experience in regulated manufacturing...SeniorRegulatoryFull time
$124k - $180k
...healthier future for all.As a Principal Scientist you will serve as a central technical... ...characterization that guarantees formulation parity, regulatory compliance, and consumer safety across... ...working within a GxP (GLP/GMP) regulated environment with a strong understanding...SeniorRegulatoryHourly payLocal areaRelocationShift work$173.2k - $272.6k
...leader for the role of Senior Director,... ...analytical, technical, and regulatory deliverables.The... ...lead a team of scientists, operational experts... ...submissions, clinical supply, and lifecycle... ...oversight of stability study design, protocol... ...management in a regulated pharmaceutical...SeniorRegulatoryFull timeFor contractorsLocal areaFlexible hours- ...and visit About the Role: Hims & Hers is seeking a Senior Scientist, Regulatory & Clinical Operations to join our growing laboratory organization... ...R&D and serve as the clinical coordinator for our FDA-regulated study, working directly with our contracted CRO to own execution...SeniorRegulatoryFull timeInterim roleLocal areaRemote workFlexible hours
- Job DescriptionEisnerAmper is seeking a Senior Consultant - FEMA in our Government Services... ...of and experience with relevant FEMA regulations and policies and processes.What Work You... ....· Keeping up with ever-changing regulatory requirements, Governmental Accounting Standards...SeniorRegulatoryFull timeWork at officeLocal area
$173.2k - $272.6k
Job DescriptionThe Clinical Imaging Scientist (Principal Scientist) leads complex... ..., supporting programs from study planning through closeout.The... ...Imaging, Imaging Leads, Senior Clinical Imaging Scientists... ...imaging service providersProvide regulatory-facing imaging expertise to...RegulatoryFull timeFor contractorsLocal areaRemote workFlexible hours- Overview Senior Business Analyst (Insurance/TPA background in Health, Annuity and Life)... ..., claim adjudication processes, and US regulatory requirements. This role requires excellent... ...guidelines, and compliance with US regulations. Conduct in-depth gap analysis to identify...SeniorRegulatoryContract work3 days per week
$85.8k - $143k
...statistical models.Conduct business in compliance with regulatory guidance including SR (Supervision and Regulation Letters) 10-1, SR 10-6, SR 11-7, Enhanced... ....Scope of Responsibilities:The position serves as senior analyst in the use of statistical programming languages...SeniorRegulatoryFull timeWork experience placementSecond jobWork at officeRemote work- ...reach your goals. EisnerAmper is seeking a Senior Consultant - CDBG-DRin our Government... ...knowledge of and experience with relevant HUD regulations and guidance.Note: this could be either... .... Keeping up with ever-changing regulatory requirements, Governmental Accounting Standards...SeniorRegulatoryFull timeWork at officeLocal areaRemote work
- Title: Lead/Senior Business Analyst - Medicare insurance domain Location: Piscataway,... ...Ensure all solutions adhere to Medicare regulations, industry standards, and best practices.... ...Keep up-to-date with industry trends, regulatory changes, and best practices in Medicare...SeniorRegulatoryContract work
$195.2k - $250k
...brighter, healthier future for all.As the Senior Director, Environmental, Health & Safety... ...), external interface, and supporting regulatory and legislative inquiries Lead environmental... ...of US (OSHA, EPA, DOT)/state EHS regulations A proven track record of navigating complex...SeniorRegulatoryHourly payLocal areaRelocation package$145.47k - $176.27k
...administered to patients in clinical studies. Our team is involved at... .... Position Summary The Senior Principal Scientist will serve as a CMC Analytical... ...guidelines and global regulatory requirements and has... ...data privacy policies and regulations. R1603904 : Senior Principal...SeniorRegulatoryHourly payFull timeTemporary workPart timeSummer workLive inRemote workFlexible hoursShift work- ...across the research and clinical trials landscape. By... ...and enthusiastic Senior Clinical Research Coordinator... ...specimens and study documentation of patient... ...applications and preparation of regulatory documents, study... ...to all applicable regulation and study protocol....SeniorRegulatoryFull timeTemporary workWork at officeRemote work
- A Clinical Trial Manager with 3-8 years of experience... ..., applicable regulations, and company SOPs. Manages study timelines, vendors, budgets... ...compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements. Have... ...regular updates to senior management. Review monitoring...SeniorRegulatory
$136.6k - $171.9k
...Description Summary: The Senior Manager, Clinical Operations is responsible... ...compliance with applicable regulatory requirements, ICH-GCP guidelines... ...Procedures (SOPs), and study protocol. The Senior Manager... ...and global clinical trial regulations. Demonstrated ability to...SeniorRegulatoryFull timeContract workTemporary workWork experience placementWork at office$96.8k - $137k
...locations as needed.Manage multiple stability studies at the lab, pilot and plant scale,... ...required documentation under GMP/GLP per FDA/ICH guidelines as required. Maintain a clean... ...including those for product development, regulatory and safety.Deliver effective...SeniorRegulatoryHourly payLocal areaRelocation$81 - $155 per hour
...Senior Financial Analyst I Recruitment/Posting Title - Senior... ...Institute for Nicotine and Tobacco Studies (formerly Rutgers Center for... ...a Tobacco Center for Regulatory Science, the Center of Excellence... ...budgeting and federal guidelines/regulations pertaining to Research and...SeniorRegulatoryFull timeShift work- ...Description: Job Summary The Senior Environmental Health & Safety... ...adherence to all applicable regulatory requirements while fostering... ...EHS standards and regulations. Performs research and provides... ...environments (such as FDA or cGMP-regulated industries)...SeniorRegulatoryFull timeFor contractorsInterim roleFlexible hours
- ...Job Summary: We are seeking a Senior Business Analyst - Veeva Vault Quality to support... ...between Business and IT teams in a GxP-regulated environment. Roles &... ...stakeholders across Quality Assurance, Regulatory Affairs, and Compliance. lign stakeholder...SeniorRegulatory
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