- Bristol Myers Squibb (Devens, MA)
- …and Good Documentation Practices. + Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines ( FDA , EU) and the ... configurations, data integrity, cyber security, and defends their work before regulatory agencies. + Ensures alignment with BMS directives and industry guidelines… more
- Beth Israel Lahey Health (Boston, MA)
- …just taking a job, you're making a difference in people's lives.** The Sr. Regulatory Specialist supports regulatory compliance for clinical research at Beth ... deviations and submission of other study documents to support regulatory compliance . Troubleshoot processes and procedures when.... Preparation and submission of annual reports to the FDA . Submission of regulatory documents to NIH/OBA… more
- Dana-Farber Cancer Institute (Boston, MA)
- …submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal ... work with amazing partners, including other Harvard Medical School-affiliated hospitals. ** Regulatory Compliance ** + Prepares and submits all protocol… more
- Takeda Pharmaceuticals (Boston, MA)
- …the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. + ... maintain compliance for products. + Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. + Participates with… more
- Philips (Cambridge, MA)
- …Products meet FDA , and other governmental agency/notified body Regulatory Compliance standards/requirements. **Your Role:** + Leads business critical ... protocols. + Providing guidance on current, new and updated Regulatory compliance procedures globally, such as CE...and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, compliance with FDA 's guidance documents, and including… more
- CGI Technologies and Solutions, Inc. (Burlington, MA)
- …and QA activities for the organization's Quality Management Systems (QMS), ensuring compliance with pharmaceutical regulatory requirements ( FDA , EMA, etc.). ... be responsible for managing the validation activities, quality assurance processes, and regulatory compliance for pharmaceutical projects. This role requires a… more
- Takeda Pharmaceuticals (Boston, MA)
- …the global regulatory strategy is updated and executed, ensuring global regulatory compliance . + Ensures global regulatory strategies defined within ... to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. + Is a leader both in… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ready to ... our teams accelerate progress. This individual will be responsible for providing regulatory review and approval of US promotional and other product and… more
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is accountable ... medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject… more
- Fresenius Medical Center (Waltham, MA)
- …of pharmaceutical products. + Ensure compliance with local and global regulatory standards, including FDA , EMA, ICH, and other regulatory ... advocate for regulatory positions, influence decisions, and expedite approvals. + Regulatory Risk Management & Compliance : + Identify and manage … more