- Sanofi Group (Cambridge, MA)
- …the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions ... in the project, Global Project Head, The PV Rep, Regulatory + Provide expertise in the fields of clinical...to medical questions raised by EC/IRBs, sites **Contribution to regulatory and safety documents and meetings:** + Represents his/her… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …for industry applicable to the design, analysis of clinical trials and process for regulatory submissions across difference regions (ICH, FDA , EMA and others). + ... approaches (eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in meetings with global or… more
- Medtronic (Boston, MA)
- …requirements for business continuity, operations security, cryptography, forensics, regulatory compliance, internal counter-espionage (insider threat detection and ... knowledge of cybersecurity regulations and standards specific to the medical device industry ( FDA , HIPAA, IEC 62443, NIST, NIS 2, etc.). + Drive improvements in the… more
- Sanofi Group (Cambridge, MA)
- …program strategy and the network of collaborators from research to operational, regulatory , and commercial functions. Success in this role requires the ability to ... The GPH will be delegated such responsibilities as interaction with regulatory /health authorities, approval of protocols, informed consent documents, clinical study… more
- Sumitomo Pharma (Boston, MA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Charles River Laboratories (Cambridge, MA)
- …required and advise management on safety and environmental issues. Review new regulatory standards and make compliance recommendations. * Inspect the facilities for ... and staff. * Develop and ensure adherence to pertinent regulatory requirements and to departmental policies, practices, and procedures...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Charles River Laboratories (Wilmington, MA)
- …service and compliance documentation as required by company policy, cGMP and FDA . * Responsible for resolving client testing laboratory instrument service issues. ... quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.… more
- Curia (Hopkinton, MA)
- …evaluations + Assist Site Quality Head, during inspections by regulatory authorities, including implementing inspection-readiness programs and ensuring that proper ... of 5 years of relevant work experience in an FDA -regulated pharmaceutical environment with at least 2 years in...of 3 years of relevant work experience in an FDA -regulated pharmaceutical environment with at least 2 years in… more
- Nanobiosym, Inc. (Cambridge, MA)
- …+ Support regulatory and quality processes with a focus on FDA and ISO 13485 compliance. Minimum Qualifications: + Master's Degree in Electrical Engineering ... + Strong understanding of compliance standards in regulated industries (eg, FDA , ISO 13485). + Proven track record of delivering production-quality PCBs-from… more
- System One (Devens, MA)
- …maintaining product quality and safety. + Maintain full compliance with SOPs, FDA cGMPs, DEA regulations, and other applicable federal, state, and local standards. ... Oversee documentation of production processes, ensuring alignment with all regulatory and company standards. + Act as a liaison...a GMP environment + Strong working knowledge of GMP, FDA , and DEA regulations + Excellent communication skills and… more