Senior Clinical Regulatory Strategist, Phase 2-4 Trials
Iterative Health
Iterative Health is seeking a Senior Clinical Regulatory Specialist to support compliant execution of Phase 2–4 industry-sponsored trials across our clinical research network. You will provide regulatory guidance and oversight from start-up to closeout, partnering with sites, sponsors, CROs, and IRBs to ensure timely, accurate regulatory submissions. You will drive regulatory operations, mentorship, and process improvements, helping maintain inspection-ready documentation and implement systems #J-18808-Ljbffr Iterative Health
- ...Co., Inc. in Rahway, NJ is seeking a senior clinical scientist to drive scientific planning and execution for ophthalmology trials across Phases 1-4. You will collaborate with global teams to lead study deliverables and regulatory documentation. The role emphasizes leadership...SeniorRegulatory
$50.79k
Overview The Senior Research Coordinator in the Clinical Trials Unit will be primarily responsible for... ...prepare compliance and regulatory documentation for local,... ...recruitment and scheduling, (2) study procedure... ...executing study procedures, (4) managing specimen collection...SeniorRegulatoryFull timeWork experience placementLocal area$170k - $182k
...Therapeutics, Inc. is seeking a Senior Manager, Clinical Contracts to lead negotiation and management of clinical trial agreements, budgets, and cross... ...lifecycle experience, global Phase 1-3 trial knowledge, and a strong focus on regulatory compliance, with a competitive...SeniorRegulatoryContract work$116k - $155k
About This Role The Senior Clinical Trial Transparency Specialist leads clinical... ...closely with Clinical Development, Regulatory Affairs, Medical Writing,... ...in a science related field 4+ years of relevant pharmaceutical... ...experience or equivalent 2+ years experience of global...SeniorRegulatoryTemporary workLocal area- ...powering the acceleration of clinical research to transform... ...By combining deep clinical trial expertise with cutting-edge... ...employees world-wide. As a Senior Clinical Regulatory Specialist at Iterative Health... ...the compliant execution of Phase 2-4 industry-sponsored clinical...SeniorRegulatoryTemporary workWork at office2 days per week
- ...of the Department of Medicine. The role supports planning, coordination, and execution of clinical trials involving human participants, ensuring adherence to protocols, regulatory standards, and quality controls. Strong organizational skills and data handling are essential...SeniorRegulatory
- Biogen, Inc. seeks a Senior Clinical Trial Transparency Specialist to lead disclosure activities for assigned studies, ensuring timely and compliant... ...study teams, vendors, and internal stakeholders across regulatory, medical writing, data management, and development...SeniorRegulatory
- ...Krieger Institute, Inc. in Baltimore, MD, is seeking a Senior Research Coordinator for the Clinical Trials Unit to oversee complex pediatric psychiatric... ...submissions, documentation, data preparation, and regulatory reporting, while coordinating patient visits, specimen...SeniorRegulatory
$115k - $140k
...currently seeking a Sr. CRA 2 with 4+ years of monitoring as well... ...your skills, knowledge, and clinical judgement to provide a high standard... ...for participants in clinical trials and respond to emergency... ...according to the applicable regulatory requirements. Ensure the integrity...SeniorRegulatoryWork at officeLocal areaRemote workNight shift$259k - $314k
All Jobs > Senior Director, Clinical Operations GondolaBio is a clinical-stage biopharmaceutical... ...record of leading global clinical trials, especially phase 2, and you know how to move quickly... ...(Clinical Development, Safety, Regulatory, Biometrics, Clinical Supply, CMC,...SeniorRegulatoryFlexible hoursShift work- Yale Cancer Center is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for clinical research protocols from activation through closeout. You will manage submissions, maintenance, and compliance while mentoring junior staff and guiding investigators...SeniorRegulatoryRemote job
- All Jobs > Senior Manager, Clinical Quality Larimar Therapeutics Inc... ...clinical development, regulatory affairs, and the development... ...integrity of clinical trial activities throughout... ...quality oversight for Phase I-IV clinical studies... .... A minimum of 2 years experience performing...SeniorRegulatoryLocal areaFlexible hours
$115k - $140k
Fortrea is seeking a Sr. CRA 2 in Kentucky with over 4 years of clinical monitoring experience, especially in Oncology. Responsibilities include study site monitoring, ensuring protocol and regulatory adherence, and potentially acting as a Local Project Coordinator. Candidates...SeniorRegulatoryRemote jobLocal area$103.3k - $141k
...compounds in mid- to late-phase clinical development across our... ...document packages for regulatory submissions for new and... ...approvals of clinical trials applications. May act as... ...: BS/BA degree AND 4+ years of relevant experience Master’s AND 2+ years of related experience...SeniorRegulatoryLocal area- ...experienced and highly motivated Global Regulatory Labeling Lead to provide strategic... ...of labeling decisions by senior leadership. Interpret clinical and scientific data to inform labeling... ...in biotech/pharmaceutical industry; 2+ years in global labeling/regulatory...SeniorRegulatoryWork at officeLocal areaRemote workWorldwide
$90k - $130k
...Everest Clinical Research (“Everest”) is a full-service... ...join our winning team as Senior Clinical Data Managers... ...processes to clinical trial personnel. Provide training... ...to client audits and regulatory inspections. Follow up... ...management or at least 2 year of experience as...SeniorRegulatoryContract workTemporary workWork at officeRemote workWork from homeWorldwide- Argenta seeks a Director of Quality (Clinical) for its Shawnee, KS location to lead the clinical... ...You will drive quality strategy, ensure regulatory compliance, and embed quality within... ...role requires 10+ years in quality with 4+ years in supervision, experience in GCP...SeniorRegulatory
$170k - $182k
The Senior Manager, Clinical Contracts will ensure the successful negotiation and... ...management of clinical trial-related agreements and serve... ...Ensure compliance with SOPs and regulatory guidelines, addressing QA... ...experience with global Phase 1-3 clinical trials. Oncology...SeniorRegulatoryFull timeContract workSummer workWork at officeRelocation packageMonday to Friday3 days per week- Amgen is seeking a Clinical Scientist Associate Director to lead late-phase oncology development efforts, coordinating protocol... ..., start-up, data review, and regulatory support. The role emphasizes... ...and strategic execution across trials. You will collaborate with clinical...Regulatory
- Regeneron Pharmaceuticals, Inc (USA) is seeking a Clinical Study Lead to manage the execution of clinical trials. This role encompasses overseeing timelines,... ...documentation, and ensuring alignment with SOPs and regulatory guidelines. The ideal candidate has a Bachelor's...SeniorRegulatory
- Worldwide Clinical Trials in San Antonio, TX is seeking an Associate Clinical Study Manager to oversee site-level monitoring for Phase I-IV trials, ensuring compliant, timely delivery of study... ...coordination through data and regulatory activities in a fast-paced CRO environment...RegulatoryWorldwide
- ...Process Development Senior Scientist What you... ...from Ph II/III clinical trials to marketing application... ...processes in a phase appropriate manner.... ...technical report or CMC regulatory submissions which... ...’s degree and 2 years of Life Sciences... ...Bachelor’s degree and 4 years of Life...SeniorRegulatoryFlexible hours
- ...Inc. is seeking an experienced Senior Manager/Associate Director,... ...Control to lead QC activities for clinical and commercial drug... ...spans early to late clinical phases through PPQ and registration,... ...standards, investigations, and regulatory collaboration. Based in either...SeniorRegulatoryWork at office
- Worldwide Clinical Trials seeks a Project Manager to oversee one or more Phase I-IV clinical trials, locally, regionally or globally. You will be accountable for overall... ...ensure solutions are implemented. Travel and regulatory knowledge are essential to support global...RegulatoryWorldwide
$90k - $180k
## Senior Project Manager/Clinical Evaluation Reporting (on-site)Candidatar-selocations:... ...reimbursement, the Freedom 2 Save student debt program and... .... The primary function of a Regulatory Project Manager, Clinical... ...2017/745, MEDDEV 2.7/1 Rev 4, MDCG Guidance documents, and...SeniorRegulatoryWork experience placement- ...Requisition Number PRN45889B Job Title Clinical Trial Nurses (R.N.) Working Title... .... Adhere to federal and regulatory requirements regarding patient... ...a contribution rate of 14.2% ! Additional benefits include... ...bachelor’s (or equivalency) + 4 years or a master’s (or equivalency...RegulatoryFull timePart timeWork experience placementWork at officeMonday to FridayFlexible hoursShift workAfternoon shiftEarly shift
$68k
...Cancer Ctr MBU Department: Massey Clinical Trials Office Department Summary:... ...Days, 12+ State Holidays, and 4 Days to volunteer; Medical, Dental... ...drives study coordination and regulatory management with participant... ...active clinical RN licensure; 2+ years of relevant experience...RegulatoryFull timeTemporary workWork at officeLocal areaRemote workFlexible hours- ...Cancer Center at VCU is seeking a Clinical Research Nurse (CRN) to... ...activating and managing clinical trials in a busy research environment... ...Nursing and active RN licensure; 2+ years in clinical research... ...tools; includes strong regulatory knowledge and IRB compliance;...RegulatoryWork at office
- Pacific Life is seeking a Senior Claims Specialist - Short Term Disability to lead end-... ...of complex STD claims, partnering with clinical and vocational resources to support RTW... ...in Chattanooga, TN, and requires strong regulatory knowledge (FMLA, ERISA, HIPAA) and mentorship...SeniorRegulatoryRemote jobTemporary work
- ...best talent for a Senior Scientist, Protein... ...technologies and delivering phase-appropriate characterization across clinical development and... ...reports, and regulatory-supporting documents... ...Required: Minimum of 4 years’ experience... ...Master’s degree or 0-2 years’ experience...SeniorRegulatory
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