Remote Regulatory affairs Jobs

Job listings

  • Lead global pharmacovigilance operations for clinical trials and post-marketing safety.
  • Ensure regulatory compliance with FDA, ICH, and GVP standards across international markets.
  • Build and mentor high-performing teams while driving business development and financial performance.

The company is a fast-growing clinical research organization specializing in pharmacovigilance and drug safety. It emphasizes operational excellence, regulatory compliance, and patient safety, with a global reach and a collaborative culture.

Unlimited PTO

  • Provide QA oversight for CMC drug product and device operations, ensuring compliance with global GMP regulations.
  • Approve protocols, batch records, and disposition batches for clinical trials in partnership with external vendors.
  • Support health authority inspections and regulatory filings, driving continuous improvement in sterile manufacturing.

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases through innovative anti-FcRn therapies. As a growing biopharmaceutical firm, the company fosters a dynamic, entrepreneurial culture with a focus on compliance and patient safety.

  • Conduct remote audits of medical device quality management systems against ISO 13485 and EU MDR.
  • Review objective evidence, identify findings, and deliver structured audit reports.
  • Apply sound regulatory judgement and support continuous improvement of audit processes.

The partner company specializes in assessing innovative health technologies and ensuring regulatory compliance for medical devices. It operates with a quality-focused culture, valuing autonomy and regulatory expertise.

US Unlimited PTO

  • Provide strategic leadership and oversight for all clinical data management activities across the development program.
  • Partner with cross-functional leaders to ensure data integrity and support timely, high-quality decision making.
  • Oversee vendor management, data governance, and delivery of inspection-ready clinical data.

Akero Therapeutics is a clinical stage biopharmaceutical company focused on developing transformational treatments for serious metabolic diseases like MASH. They are a team of problem solvers with a collaborative culture, dedicated to bringing out the best in each other.

12w maternity 12w paternity

  • Provide expert knowledge on day-to-day clinical pharmacology workflows for regulatory submissions.
  • Identify common tasks and problems where AI can add value in pharmacology workflows.
  • Generate and review ground-truth artifacts to evaluate AI platform outputs for regulatory-grade quality.

Edison Scientific builds and commercializes AI agents for science to accelerate scientific discovery. They are assembling a team of top researchers and engineers across AI and biology to build an AI scientist, fostering a fast-moving, mission-driven culture.

$130,000–$135,000/yr

  • Manage provider and clinic compliance relationships, including onboarding and edge case resolution for approximately 3,500 clinics.
  • Lead investigations into prescribing pattern anomalies and credential lapses, producing written summaries and communicating outcomes.
  • Build and deliver compliance training for the sales team and develop provider-facing educational materials.

Strive Pharmacy is a personalized compounding pharmacy focused on individualized care and genuine partnership with patients and providers. The company is growing and seeks people who share their conviction for a more human approach to healthcare.

  • Conduct quality control reviews of participant visits and source documentation in the CRIO eSource system to ensure compliance with GCP, ALCOA principles, and client standards.
  • Identify missing documentation, inconsistencies, protocol deviations, and transcription errors, and document findings in tracking systems.
  • Collaborate with site personnel to communicate findings, support corrective actions, and contribute to continuous improvement initiatives.

UniTriTeam is a women-owned global workforce solutions organization specializing in clinical research operations, technology, and strategic staffing support. The team is collaborative, accountable, and committed to delivering excellence and integrity.

$270,000–$300,000/yr

  • Provide strategic regulatory leadership for cell therapy portfolio including commercial readiness and labeling.
  • Lead global health authority interactions including FDA, EMA, and negotiations for labeling and approvals.
  • Oversee submissions, mentor a high-performing team, and align regulatory strategy with business objectives.

Kyverna is a biotechnology company developing autoimmune cell therapies. As a late-stage organization, it fosters a collaborative culture in a fast-paced, high-growth environment.

  • Develop global clinical strategies to support clinical evidence requirements for product submissions.
  • Ensure adequate monitoring is conducted on all clinical trials and work directly with regulatory bodies for approvals.
  • Select, interface with, and assure training of investigators, physicians, and clinical staff.

Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs to enhance patients' lives, and supplies high-end niche batteries for specialized markets. We are guided by six Values: Customer, Innovation, Collaboration, Inclusion, Candor, and Integrity, fostering a culture of passionate excellence within our team of over 10,000 employees.

  • Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting for clinical trials.
  • Serve as the internal project manager for assigned oncology disease groups, providing timely updates and regulatory guidance.
  • Manage study activation processes and act as liaison between sponsors, investigators, and internal departments.

Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. Winship Cancer Institute is Georgia's only NCI-designated Comprehensive Cancer Center, dedicated to discovering cures for cancer and providing innovative therapies.