Regulatory Affairs Lead, Clinical Trials (Remote)
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You will lead Yale's Clinical Trials Office regulatory division, directing Regulatory Managers, Regulatory Affairs Specialists, and Research Assistants. You will develop workflows, implement policies, monitor compliance, and educate colleagues to support the corporate regulatory infrastructure. The role requires expert knowledge of federal regulations governing human subjects research and strong leadership to drive best-in-class operations within the CTO. #J-18808-Ljbffr Remote Jobs
- 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...Remote job
- Yale Cancer Center is seeking an Assistant Director of Regulatory Affairs to lead the CTO regulatory division in New Haven. You will guide... ...specialists, and promote compliant operations across the Clinical Trials Office. You will shape policy, monitor performance, and...Remote jobWork at office
- ...Therapeutics is seeking a highly motivated Clinical Trial Site Activation Lead to drive late-stage site activation... .... You will manage feasibility, regulatory submissions, and site readiness,... ...ensuring compliance. In this hybrid/remote-friendly role, you will influence senior...Remote job
- ...Reports to: Reports to the VP, Clinical Operations SPI is seeking a... ...experienced and organized TMF Lead to support the operational... ...smooth execution of clinical trials from start-up to close-out, work... ...compliance with ICH-GCP and regulatory standards. This role offers hands...Remote jobWork from homeFlexible hours
- ...strategic partner across Novartis and external service providers, driving compliance, data quality, and timely trial execution. This role can be based remotely anywhere in the U.S., with up to 30% travel; visa sponsorship is not provided. The position emphasizes...Remote jobFree visa
- Remote: You will be able to work from your home location within the... ...and the value chain. Leads the implementation, monitoring... ...and other applicable legal and regulatory requirements.This individual... ..., Internal Audit, Regulatory Affairs, and Data Protection, influencing...Remote workFull timeWork at officeWork from home
- Syneos Health in the United States is seeking a Senior Clinical Research Associate (Sr CRA) to support site monitoring across the drug development continuum. You will perform on-site and remote visits, ensure ICH-GCP compliance, and partner with investigative sites to...Remote work
- ...Solutions is seeking a Senior Compliance Specialist to support its regulatory affairs team. This subject matter expert will ensure compliance with... ...5 years of experience in trade compliance. The role is fully remote, providing significant flexibility while working with a...Remote work
$370k - $400k
...Director, Asset Strategy Lead and Clinical Lead, Early... ...studies, and potentially regulatory approval and commercialization... ...Commercial, Medical Affairs, Regulatory, and... ...several clinical trials across the continuum... ...by federal, state, or local law. #Li-Remote...Remote workFull timeWork at officeLocal area$115k - $185k
...A medical device company is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and strategy for new product development. This role offers flexibility in levels and can be remote, aligned with US East Coast hours. Candidates should have a Bachelor...Remote work- ...California to drive physician awareness and adoption of our AI-powered clinical trial services among oncology providers. You will educate... ...work primarily in the field with significant travel The role is remote with a home-based office in your territory, requiring 70-75% field...Remote jobWork at officeWork from home
- ...Driving the successful delivery of clinical trials across multiple countries, the full-time Regional Project Lead will manage project planning, implementation, and compliance... ...ensuring the highest quality standards in a remote environment. Key responsibilities Ensure...Remote workFull time
$144.06k - $205.8k
...global leadership role in the Regulatory Affairs department for the Chemistry... ...:Acts as a CMC regulatory lead for highly complex projects/... ...eCTD Module 3 documents for clinical trial and registration filings.Actively... ...based in Westborough, MA. Remote work from anywhere in the US...Remote workWork at officeLocal areaWork from homeWorldwide$177k - $278.08k
...worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the... ...broad concepts within regulatory affairs and implications across the organization... ..."hybrid" following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1Takeda Compensation...Remote workMinimum wageTemporary workLocal areaWorldwide- ...SummaryThe Director, Global Regulatory Strategy- Oncology is... ...Global Regulatory Lead responsibilities for one... ...activities and key meetings. Remote-first candidates may be... ...in Regulatory Affairs within the pharmaceutical... ...spanning multiple phases of clinical development.3+ years of...Remote workFull timeLocal area
- ...Therapeutics, based in Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene... ...submissions. This position promotes a collaborative work environment with flexible remote options. #J-18808-Ljbffr Jobleads-USRemote workFlexible hours
$169.5k - $248.6k
...About the RoleAs the Global Regulatory Lead (GRL), you will be the accountable... ...of experience in regulatory affairs and/or drug... ...JapanDirect experience in both clinical and CMC regulatory sciencesStrong... ...and relocation is provided, remote is not available for this role...Remote workLocal areaRelocationFlexible hours- ...world for future generations. Position Summary: The Global Regulatory Affairs Lead is responsible for defining and executing Oath’s... ...certification (e.g., PMP) is a strong plus. Location: Home-based / Remote (USA-based preferred for proximity to North American R&D andcommercial...Remote workLocal areaWork from homeShift work
- ...Telix Pharmaceuticals Limited is seeking a Global Product Development Lead (Early-Stage) to drive the development of targeted therapies through clinical trials. This critical role requires managing cross-functional teams and executing the drug development plan. The...Remote work
- ...possess strong knowledge of ICH GCP guidelines, excellent communication skills, and a keen attention to detail. The position is fully remote for those in or willing to relocate to Maryland, Virginia, or Washington D.C. The company is committed to diversity and equal...Remote workRelocation
$130k - $155k
A healthcare organization is seeking a Principal Clinical Data Manager to lead and oversee clinical trial data processes. This remote role offers a chance to work with leading global healthcare organizations while ensuring compliance with industry standards. Responsibilities...Remote job$258.68k - $313.46k
...Director, Global Regulatory Strategy, NeuroscienceWill... ...Global Regulatory Lead and US Regional... ...BMS, regulatory affairs or projects and... .../Biopharmaceutics/Clinical/Promotional.Inter-... ...centers. Employees in remote-by-design or lab-... ...in clinical trials, while our shared...Remote workHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work- VB Spine, a leading privately held spine company, is seeking a Sr. Staff Regulatory Affairs Specialist to drive global regulatory strategies for complex medical devices. This role partners with cross-functional teams to support development, lifecycle management, and submissions...Remote job
- Travere Therapeutics in San Diego, CA is seeking an Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for biologics across development and commercialization. You will partner with cross-functional teams to align CMC plans with regulatory requirements...Remote job
$97k - $193k
Worldwide Clinical Trials is looking for a Clinical Research Associate (CRA) to oversee research activities in clinical studies across diverse... ...team, ensuring that studies run smoothly and comply with regulatory requirements. This role requires 5+ years in a similar...Remote jobWorldwide- NewAmsterdam Pharma Corporation is seeking a Senior Manager CMC Regulatory Affairs to oversee global CMC regulatory strategies for clinical development programs and marketing applications. The role is remote and emphasizes collaboration with various departments to ensure...Remote job
- Innolitics LLC is a remote-first medical device consultancy hiring a Senior Regulatory Affairs Specialist to lead regulatory engagements for AI/ML-enabled SaMD. You will shape regulatory strategy, advise on FDA AI/ML framework, and drive Fast 510(k) sprints to completion...Remote job
- ...Provider Account Manager to expand awareness and adoption of our clinical trial services among oncology providers outside of trials. You will... ...trial matching and guide referrals through enrollment. This remote, field‑based role requires strong communication, a minimum of...Remote job
- ...pharmaceutical company is seeking an Associate Director for Global Regulatory Affairs. This role involves acting as a Subject Matter Expert and... ...and strong interpersonal and communication skills. This position allows for remote work options. #J-18808-Ljbffr BioSpaceRemote work
- Advita Ortho in the US (Remote) seeks a Sr Manager, Regulatory Affairs to provide strategic leadership for the postmarket regulatory team, directing regulatory strategies, submissions and ongoing compliance for commercialized orthopaedic products. You will collaborate...Remote job
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