- Takeda Pharmaceuticals (Boston, MA)
- …+ Oversees and leads all clinical science activities involved in interactions with FDA , other regulatory agencies and key opinion leaders relevant to assigned ... development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency… more
- Nanobiosym, Inc. (Cambridge, MA)
- …+ Lead molecular diagnostic assay development in a hands-on manner through successful FDA submission + Manage and contribute to regulatory documents + Project ... leadership expertise in assay development + Strong understanding of FDA and global regulatory requirements + Prefer...+ Strong understanding of FDA and global regulatory requirements + Prefer commercial assay experience + Demonstrated… more
- Takeda Pharmaceuticals (Boston, MA)
- … submissions. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing ... bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global … more
- Philips (Cambridge, MA)
- …new product development projects, ensuring our state-of-the-art Ultrasound Products meet FDA , and other governmental agency/notified body Regulatory Compliance ... if:** + You have a minimum of 8+ years' Regulatory Affairs experience within FDA regulated Medical...of 8+ years' Regulatory Affairs experience within FDA regulated Medical Device/HealthTech product environments. Experience with Software… more
- Sumitomo Pharma (Boston, MA)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions, clinical study reports, and NDA/MAA… more
- Takeda Pharmaceuticals (Boston, MA)
- … submissions. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing ... + Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... when Fuji Dictation software is utilized. + Maintains a clear understanding of FDA requirements and ACR recommendation as well as local state regulations for… more
- Abbott (Westford, MA)
- …work environment. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA , GMP, and all other applicable agency regulations. + Ensure a safe work… more
- Sanofi Group (Cambridge, MA)
- …endpoint strategy implementation + Knowledge of the drug development process and the regulatory ( FDA , EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, ... new COA instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research and Development… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... level of customer satisfaction. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties… more