Clinical Regulatory Lead - FDA/ICH & IRB Oversight
AMR Lexington
AMR Lexington is seeking a Regulatory Manager to oversee regulatory activities for clinical research studies. This full-time position involves managing a regulatory team, ensuring compliance with FDA regulations, and developing strategies for efficient regulatory processes. The ideal candidate will have 5-8 years of experience in the regulatory field, advanced knowledge of electronic regulatory software, and strong leadership and communication skills. The position is located in Idaho, United States. #J-18808-Ljbffr AMR Lexington
$152k - $209k
...of our business. The Clinical Quality Lead is responsible for driving... ...real‑time quality oversight and consistent high‑... ...with GCPs, regulatory requirements, and argenx... ...and EU regulations and ICH GCP Guidelines. Knowledge... ...assurance experience. FDA, EMA, MHRA, PDMA...RegulatoryTemporary work$80 - $90 per hour
...Remote - Regional Clinical Operations Lead • A highly reputable biotechnology... ...operational execution, oversight and management of one or... ...Clinical Data Management, Regulatory, Biostatistics, Pharmacology... ...Procedures (SOPs), FDA regulations and ICH/GCP guidelines with minimal...RegulatoryContract workCurrently hiringRemote work- ...looking for a Director, Medical Chair who will lead IRB board meetings and provide strategic medical oversight. The ideal candidate holds a Doctor of Medicine... ...years of senior-level experience, particularly in regulatory and ethical issues. This position combines executive...RegulatoryRemote work
$148.3k - $241.9k
The Senior Clinical Study Lead (CSL) is expected to operate with high-degree... ...Operating Procedures (SOPs) and ICH/GCP. This role applies to... ...of direct leadership versus oversight will vary accordingly.... ...documents Knowledge of ICH/GCP and regulatory guidelines/directives...RegulatoryLocal area- Clinical Study Lead Responsibilities The Clinical Study Lead (CSL) may perform... ...with moderate oversight: Accountable for the global... ...accordance with Regeneron SOPs, ICH/GCP. Contribute to and drive... ...knowledge of ICH/GCP and relevant regulatory guidelines. Effective project...Regulatory
$153.6k - $241.34k
...OBJECTIVES: Develop and lead the program-level... ...other vendors. Represent Clinical Operations at the Global... ...sponsor’s operational oversight of our strategic partners... ...into preparation for key regulatory meetings as appropriate... ...to US CFR, EU CTD, and ICH GCP. Awareness of local...RegulatoryMinimum wageTemporary workLocal areaNight shift$70k - $90k
Albert Einstein College of Medicine is looking for an IRB Analyst with at least 3 years of IRB experience and a Bachelor’s Degree. The role involves regulatory oversight, communications with the research community, and participating in educational initiatives related to...Regulatory$37 - $48.52 per hour
...Day Shift Description: RN Clinical Lead - Troy Health Center - Troy, NY - FT... ...monthly temp logs ~ Site walkthrough for regulatory issues (stock, expiration, compliance)... ...be included in the responsibilities and oversight of the RN Clinical Lead. Qualifications...RegulatoryHourly payFull timeTemporary workWork at officeLocal areaMonday to FridayShift workDay shift€58k - €96.5k per year
...Responsible for the clinical operations of a project within a defined... ...regional/global level. Provides oversight of project deliverables,... ...Good Clinical Practice (GCP), ICH guidelines and local regulations... ...relate to clinical monitoring, IRB/EC and Investigator responsibilities...Permanent employmentTemporary workLocal areaWork from home- ...A leading medical technology company is seeking a Clinical Operations Quality Manager to manage clinical trials and ensure quality oversight. The role involves leading the execution of clinical studies... ...maintaining compliance with regulatory standards. Ideal candidates have...RegulatoryRemote work
- ...We’re hiring: Clinical Development Lead (US – Remote) At Prothya Biosolutions, we are looking... ...cross-functional stakeholders Driving FDA interactions and regulatory alignment Ensuring studies are... ...preferred / required) Strong knowledge of ICH-GCP and FDA regulations Excellent...RegulatoryRemote work
$38 - $50 per hour
...Pediatrics is building the nation's leading pediatric multispecialty... ...Registered Nurse (RN) - Clinical Lead to join our dynamic outpatient... ...LL DO Clinical Leadership & Oversight Supervise and support... ...initiatives and ensure compliance with regulatory standards. Patient Care &...RegulatoryHourly payWork at office$120k - $180k
...to strengthen and scale its clinical platform. With continued site... ...supporting clinical teams, ensuring regulatory compliance, improving the... ...coordination, and cost oversight Ensure adherence to healthcare... ...accreditation expectations Lead onboarding, training, and...RegulatoryLocal areaFlexible hoursAfternoon shift$80k - $85k
...barriers to care. We’re seeking a Clinical Supervisor (LCSW/LCSW-R) to lead and strengthen our OMH outpatient... ...Responsibilities Clinical Leadership & Program Oversight Provide on-site clinical... ..., documentation quality, and regulatory compliance Monitor admissions, discharges...RegulatoryWeekend workAfternoon shift- ...ensuring nuclear operations are safe through monitoring and compliance activities. The ideal candidate will perform oversight reviews, participate in regulatory inspections, and provide technical guidance in emergency preparedness. Applicants must possess a bachelor’s...RegulatoryFull timeRemote work
$100k
Article-31 Mental Health Clinical Lead Manager (LCSW or Ph.D./PsyD) - Bronx, NY - Job ID# 44... ...Manager provides clinical and operational oversight to ensure high‑quality, evidence‑based... ...staff, ensures compliance with regulatory standards, and collaborates with interdisciplinary...RegulatoryFull time- ...President, Senior Compliance Officer, Monitoring & Compliance Oversight About the Company Leading global financial institution with broad exposure to... ...with a strong background in monitoring, testing, and regulatory compliance, particularly within complex financial...Regulatory
- ...Associate for its Capital Risk & Governance team in New York. This role involves providing critical oversight of capital management, ensuring compliance with regulatory requirements, and fostering a positive risk culture. Candidates should have a 4-year degree, along with...Regulatory
- ...seeking a senior-level data science leader to drive advanced analytics and AI-enabled oversight solutions in support of CMS Marketplace compliance programs. The role blends regulatory analytics, system design, and audit support. This position is fully remote and offers...RegulatoryRemote work
$133.35k - $155k
Associate Director, Reliance and IRB Operations Grade: 32 Salary: $133,353 - $155,000... ...federal regulations. Serve as the primary regulatory resource for researchers, sponsors, and... ...governing human subjects research (e.g., OHRP, FDA, and HIPAA). Preferred: Advanced degree...RegulatoryWork at office- ...Radiometer is seeking a Senior Clinical Study Manager to lead the execution of clinical trials in the U.S. and EU for Leica Biosystems, ensuring compliance with regulatory requirements and high-quality standards. The ideal candidate will have extensive experience in planning...Regulatory
$266.4k - $399.6k
...Medtronic is seeking a leader for clinical studies and regulatory affairs to drive product approvals. The successful candidate will manage clinical research and ensure compliance with regulatory requirements, significantly impacting healthcare solutions. This position...Regulatory$183k - $228.8k
...global leader in medical technology is seeking a Senior Advisor for Regulatory and Clinical Affairs. The role involves guiding regulatory strategies for product approvals and ensuring compliance with FDA standards. The ideal candidate should have extensive experience in...RegulatoryRemote work- ...Inc. is looking for a Quality Registered Nurse (RN) to oversee clinical quality and compliance across multiple primary care clinics.... ...in clinical nursing, with a focus on quality improvement and regulatory standards. The position is primarily remote or hybrid, involving...RegulatoryRemote work
$90k - $135k
...Interest Rate Risk in the Banking Book Oversight Risk Associate Job Level: Associate Job Function: Governance & Assurance Location... ...of balance sheet products and risks ~ Understanding of U.S. regulatory requirement for IRRBB. ~ Understanding of methods and approaches...RegulatoryFull timeWork at officeLocal areaWork from home$270k - $345k
...Compliance Governance & Oversight Lead San Francisco, CA | New York City, NY | Washington, DC About Anthropic Anthropic's mission... ...with the leads of our other I&C pillars — Privacy Programs, Regulatory Programs, and Corporate Compliance — to ensure their work is...RegulatoryInterim roleWork at officeVisa sponsorship3 days per week$70k
...category determination and each level of IRB review (pre-review, re-review,... ...committee review) to ensure adherence to regulatory and ethical standards. Acts as a liaison... ...administrator will also be involved in the oversight of the Committee functions, including writing...RegulatoryWork experience placementWork at office$156k - $176.8k
...solutions company is seeking a qualified candidate for a remote clinical operations role based in Chicago, IL. The ideal applicant... ..., particularly in small molecule drug development and regulatory compliance with FDA, EU, and Japan. The role requires strong communication...RegulatoryRemote work- ...A leading biotechnology company is seeking an Associate Director, Clinical Supply to oversee the clinical trial supply chain. The ideal candidate will have more than... ...commercial supply chain management, with a focus on regulatory compliance and project management....RegulatoryRemote work
- ...Associates, Inc is seeking an Associate Director, Clinical Research Scientist in Oncology. The candidate will lead clinical research projects and represent the... ...problem-solving skills and be knowledgeable in regulatory requirements, ensuring compliance across studies...RegulatoryRemote work
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