Source Job

India

  • Prepare, review, and coordinate local Ethics Committee and regulatory submissions for clinical studies.
  • Collaborate with internal teams and study sites to align site start-up activities and ensure timely submissions.
  • Maintain accurate trial status information, local files, and current knowledge of applicable procedures and regulations.

Regulatory Submissions Clinical Research Communication Documentation

20 jobs similar to Country Approval Specialist

Jobs ranked by similarity.

Brazil

  • Support clinical trial activities across patient engagement, study coordination, recruitment, regulatory support, data management, and operations.
  • Coordinate participant visits, recruitment, and regulatory documentation while maintaining accurate information in clinical research systems.
  • Foster communication between sponsors, CROs, investigators, and sites to ensure study compliance and milestone achievement.

This partner company supports fast-growing remote clinical research environments, helping keep clinical trials organized, compliant, and moving forward. They collaborate with research sites, sponsors, CROs, and healthcare organizations globally, offering multidisciplinary roles in a remote setting.

North America

  • Coordinate day-to-day execution of clinical studies including site onboarding, documentation, and timeline tracking.
  • Support regulatory compliance through IRB submissions, amendments, and maintaining study documentation.
  • Collaborate cross-functionally with science, bioinformatics, and product teams to ensure study operations.

Tiny Health advances lifelong health through precision microbiome science using shotgun metagenomics and AI. Founded in 2020, it is a remote-first startup with a diverse international team focused on making the microbiome measurable and actionable.

US

  • Serves as regulatory document specialist for clinical trial start-up, maintenance, and close-out.
  • Collects, reviews, and maintains essential documents in the electronic Trial Master File (eTMF).
  • Communicates with study teams and sites to ensure regulatory files remain complete and inspection-ready.

St. Jude Children’s Research Hospital is a leading research and treatment center focused on pediatric catastrophic diseases. It is a large institution with a collaborative culture and a strong emphasis on finding cures and saving children.

India

  • Support accurate setup and management of clinical trial payment processes, ensuring timely and compliant financial support.
  • Collaborate with internal teams, clients, and sites to configure payment systems and resolve operational challenges.
  • Maintain data accuracy, improve workflows, and contribute to clinical research delivery.

Jobgether uses AI to match candidates with jobs, focusing on objective review and fair hiring. They operate globally with a collaborative culture and process personal data under GDPR.

US

  • Independently manages significant aspects of clinical trials and research projects.
  • Trains and provides guidance to less experienced staff, and oversees data management.
  • Ensures compliance with regulations, monitors IRB submissions, and interfaces with study sponsors.

Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate and prepare leaders for the future. The university is committed to diversity and inclusion, providing a supportive environment for staff and faculty.

US

  • Serve as the primary point of contact for assigned protocols, linking Country Operations with the clinical trial team.
  • Manage project timelines, deliverables, and performance for clinical studies from feasibility to close out.
  • Ensure compliance with ICH/GCP, country regulations, and company policies while leading local study teams.

Merck is a global healthcare leader with a diverse range of prescription medicines, vaccines, and animal health products. With over 100 years of history, the company employs tens of thousands worldwide and fosters a culture of innovation and inclusivity.

$65,000–$75,000/yr
US

  • Engage with patients to recruit, educate, and pre-screen them for clinical studies.
  • Maintain data accuracy across multiple study portals and manage data entry and queries.
  • Collaborate with site teams and PIs to ensure protocol compliance and resolve issues.

Care Access brings world-class research and health services directly to communities, working to make the future of health better for all. With hundreds of research locations and a global team, we are dedicated to ensuring every person can contribute to medical breakthroughs.

Brazil

  • Critically evaluate scientific literature and produce accurate regulatory documents.
  • Manage writing assignments across multiple projects and ensure timely delivery.
  • Work directly with clients and multidisciplinary teams on regulatory submissions.

A partner company in the pharmaceutical, biotechnology, and medical device sectors is hiring a Senior Medical Writer. The company offers a fully remote environment and opportunities to work on a broad portfolio of clinical and regulatory documents.

$56,000–$109,000/yr
US

  • Manage the intake, review, analysis, and reporting of Individual Case Safety Reports (ICSRs) and support Clinical Events Committees and Data Monitoring Committees.
  • Co-author and maintain study-specific safety documents and prepare aggregate safety reports for regulatory submission.
  • Collaborate with sponsors, study teams, and cross-functional partners to ensure data quality and compliance with GCP and GVP standards.

This partner company delivers high-quality safety services across clinical research and medical device programs. They foster a collaborative, detail-oriented environment with a focus on compliance and patient outcomes.

US

  • Prepare and maintain Trial Master Files for clinical studies, ensuring completeness and compliance.
  • Review documentation for accuracy and alignment with protocols and regulations.
  • Communicate with sponsors, project managers, and sites to resolve documentation issues.

Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. They foster an inclusive, collaborative, and respectful workplace, utilizing technology to ensure fair recruitment.

$70,000–$80,000/yr
US

  • Lead clinical data management activities for assigned studies, ensuring quality and compliance.
  • Collaborate with sponsors, cross-functional teams, and global clinical research experts.
  • Oversee study data processes from start-up through database lock, driving timely delivery.

Brazil

  • Evaluate RFPs and contribute to bid strategies for clinical supply proposals.
  • Collaborate with business development, contracts, proposals, and operations teams to align budgets and assumptions.
  • Manage multiple priorities in a fast-paced international environment while maintaining quality and accuracy.

This partner company operates in the clinical research and supply chain environment, supporting high-quality proposals and clinical trial supply management. It provides a fully remote, supportive working environment with a focus on employee health and wellbeing, offering exposure to international projects and collaboration with cross-functional teams.

US Canada

  • Prepare and maintain Trial Master Files for internal and external studies to meet sponsor specifications.
  • Communicate with sponsors, project managers, and study contacts to ensure compliance with protocols and regulatory requirements.
  • Manage multiple priorities and ensure file structure and indexing are accurate.

Celerion is a clinical research organization that uses translational medicine to accelerate drug development. The company values integrity, trust, teamwork, and respect, and is an equal opportunity employer.

UK

  • Collect, review, and prepare site and regulatory documentation for UK clinical trial submissions.
  • Support regulatory submission preparation and ICF adaptations in compliance with ICH-GCP and local regulations.
  • Liaise with investigative sites to obtain, track, and resolve outstanding documentation and maintain study tracking systems.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We seek out diverse talent with a relentless commitment to innovation and impact.

$135,000–$159,000/yr
US

  • Provide study oversight as the primary liaison between CRAs, site staff, clients, and vendors across all study stages.
  • Ensure clinical monitoring activities comply with SOPs, regulations, GCPs, and study-specific requirements.
  • Support team training, review site visit reports, and manage oversight of the Trial Master File and eTMF.

ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) trusted since 1996, delivering ethical services to pharmaceutical, biotech, and medical device companies. They foster a collaborative community where team members feel valued and empowered to make a meaningful impact on global health.

US

  • Conduct remote and onsite monitoring activities including Site Initiation, Interim, and Closeout Visits.
  • Review informed consent, source documentation, and case report forms for accuracy and completeness.
  • Identify, document, and escalate protocol deviations, data quality concerns, and compliance risks.

WHOOP is on a mission to unlock human performance and healthspan, empowering members to perform at a higher level through a deeper understanding of their bodies and daily lives. They are a leading wearable technology company with a collaborative and detail-oriented culture.

$106,000–$151,000/yr
US

  • Provide regulatory guidance throughout the clinical development lifecycle and prepare quality regulatory submissions.
  • Compile, coordinate, and review applications to regulatory authorities, including CTA/IND and amendments.
  • Represent Global Regulatory Affairs at project team and business development meetings, overseeing Regulatory Affairs Specialists.

Precision Medicine Group is a life sciences company providing clinical research, regulatory, and commercial services to biopharmaceutical clients. It fosters a collaborative, quality-focused culture and is an Equal Opportunity Employer.

$83,480–$125,220/yr
United States

  • Independently conduct on-site and remote monitoring visits (SQVs, SIVs, IMVs, COVs) per protocols and regulations.
  • Manage site relationships, perform source data verification and review, and resolve data discrepancies.
  • Track monitoring findings, escalate risks, and maintain inspection-ready documentation.

Karius is a venture-backed life science company focused on clinical metagenomics, using genomics and AI to detect infectious diseases from microbial DNA in blood. The company is dedicated to advancing diagnostic science and improving patient care.

India

  • Develop and quality-control SDTM datasets supporting clinical research and regulatory submissions.
  • Program complex SDTM datasets and trial design domains using SAS.
  • Collaborate with sponsors, data operations, and cross-functional teams to ensure timely project delivery.

This partner company is a clinical research organization that develops SDTM datasets for regulatory submissions. The environment is collaborative, fast-paced, and focused on quality and operational excellence.

$340–$510/mo
India

  • Handle inbound and outbound patient calls for appointment scheduling, reminders, and follow-ups.
  • Document interactions accurately in electronic medical records to support continuity of care.
  • Coordinate with onsite healthcare personnel and healthcare teams using digital collaboration tools.

This company partners with U.S. healthcare clinics to provide remote clinical support. It offers a structured, service-focused environment with a team of nursing professionals.