- Dana-Farber Cancer Institute (Boston, MA)
- …of study records, and resolution of data queries. + Prepare and or complete regulatory related reports and IRB submissions . Maintain and organize study ... ensuring the timely collection and shipment of protocol-required samples, maintaining regulatory binders, and ensuring compliance with all institutional, state, and… more
- US Tech Solutions (Cambridge, MA)
- …difficulties + Contributes to internal/external reports, papers, presentations, regulatory documents, invention disclosure submissions and/or patents ... + Participates in department-wide support efforts such as safety, recruiting and committees + May train staff and/or supervise others + Coordinates and organizes resources needed to complete the task + Understands when to seek input and when to make… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Regulatory Strategist **Location:** Morristown, NJ/Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The race is on to ... in helping our teams accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL),… more
- Canon USA & Affiliates (Boston, MA)
- ** Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is ... handling, coordination of product recalls, FMI processes, processing electronic submissions and state registrations. **RESPONSIBILITIES** + Remote position, **west… more
- Eversource Energy (Westwood, MA)
- … regulatory expectations\. ** Regulatory & Compliance Support:** Support regulatory filings and rate case submissions \. **Technology Integration:** Support ... plays a critical part in ensuring system reliability, maintaining regulatory compliance, and cost\-effective long\-term infrastructure planning\. The successful… more
- Beth Israel Lahey Health (Boston, MA)
- …Bank (NTDB). This involves data review, validation and compilation to ensure regulatory compliance and accreditation. Data submissions are quarterly. (essential) ... data validation processes as accuracy of data is paramount to maintain regulatory compliance and accreditation. (essential) 6. Serves as active participant in the… more
- Sumitomo Pharma (Boston, MA)
- …teams. Regulatory Interactions: + Prepare and present clinical data to regulatory agencies (FDA, EMA) during IND submissions , clinical study reports, and ... programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory , Early Clinical Development, Pre-clinical research, Medical Affairs and… more
- Sanofi Group (Cambridge, MA)
- …+ Broad experience in clinical development or post-marketing activities such a submissions , interactions with regulatory agencies or other external stakeholders ... for safety analysis, including quality, relevance to external stakeholders (eg regulatory authorities, medical journals), and scientific validity. + Accountable for… more
- Sanofi Group (Cambridge, MA)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and ... Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than...lifecycle management activities for device aspects of combination product submissions . + Contribute to product development planning, including strategies… more
- Sumitomo Pharma (Boston, MA)
- …in risk mitigation strategies preferred. + Experience preparing safety reports and submissions to FDA, EMA, and/or other regulatory authorities. + Effective ... Investigator Brochures (IBs), informed consent forms (ICFs), protocols, study reports, regulatory reports, and regulatory responses. + Contribute to signal… more
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