- Takeda Pharmaceuticals (Boston, MA)
- …to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. + Is a leader both in the ... the global regulatory strategy is updated and executed, ensuring global regulatory compliance . + Ensures global regulatory strategies defined within the GRT are… more
- Philips (Cambridge, MA)
- …updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and submission types. Working under general ... preparation, assembly, review and publication of regulatory submissions to the FDA , EU and other worldwide government agencies. Ensure regulatory submissions are… more
- Sumitomo Pharma (Boston, MA)
- …relevant external advertising & promotional regulations or codes of practice (eg, FDA regulations, PhRMA guidelines, etc.) and are consistent with company guiding ... of promotional materials, eg Marketing and their Agencies, Legal, Compliance , and Medical Affairs. + Provide appropriate oversight of...with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on … more
- Takeda Pharmaceuticals (Boston, MA)
- …lifecycle + Subject matter expert on EFPIA, IFPMA, and FDA code/regs, guidance, industry standards, complaints/violations, and innovative promotional platforms ... Regulatory Subject Matter Expert: Provide expertise on EFPIA, IFPMA, and FDA codes, regulations, guidance, industry standards, and innovative promotional platforms.… more
- Kelly Services (Marlborough, MA)
- …suppliers. The ideal candidate will also bring expertise in validation processes and FDA Design Controls and serve as a technical mentor within the organization. ... and cross-functional collaboration. + Interface with external suppliers to ensure quality, compliance , and timely delivery of components and systems. + Develop and… more
- Fresenius Medical Center (Waltham, MA)
- …+ Ensure compliance with local and global regulatory standards, including FDA , EMA, ICH, and other regulatory bodies, to maintain market access and product ... to ensure timely approval and market access across key regions (eg, FDA , EMA, Health Canada, etc.). Including global chemistry, manufacturing, and controls writers… more
- Staples (Framingham, MA)
- …harmonize and support the execution of safety and regulatory compliance programs including: . Workplace Safety, Hazardous Substance management (Transportation ... team to support the implementation and execution of regulatory compliance programs designed to protect the environment, assets and...required by OSHA, EPA, DOT, FMCSA and the US FDA . Works closely with Risk Management and field operations… more
- Candela Corporation (Marlborough, MA)
- …monitor test results and defects, and generate final traceability reports, in compliance with design controls and all regulatory requirements. . Address End-of-Life ... and maintainability trends . Operate Sustaining Engineering activities in an FDA regulated environment that meets internal quality requirements and regulatory… more
- Fujifilm (Boston, MA)
- …on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations specific to Life Sciences/Pharma companies. + Provide ... to HLUS and its subsidiary companies on substantive legal topics, including FDA marketing and advertising regulations and other regulations specific to Life… more
- Sanofi Group (Cambridge, MA)
- …counsel concerning a broad range of legal issues, including, interpretation of FDA and other regulations, including the False Claims Act, Anti-Kickback Statute and ... legal issues (focusing on antitrust matters, potential litigations and promotional matters, FDA /regulatory issues and fraud and abuse) as well as proposed solutions… more