- Parexel (Boston, MA)
- …Consultant level role, 7+ years for a Senior Consultant * Proven success in preparing regulatory documentation for FDA , EMA, and Health Canada (IND, NDA, DMF) * ... experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory ...Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure… more
- Oracle (Boston, MA)
- …of Technical Staff to play a critical technical leadership role to ensure FDA and global regulatory compliance, including secure design, architecture and ... Risk-Based Process and ensure product is maintaining compliance to FDA and other Global regulatory requirements. -...maintaining compliance to FDA and other Global regulatory requirements. - Proficiency in the Java programming language.… 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
- Philips (Cambridge, MA)
- …architecture, and IT performance optimization projects. + Ensure all solutions comply with FDA validation and regulatory requirements. + Monitor and report on ... degree in information technology engineering or computer science. + Strong understanding of FDA validation, ITIL processes, and regulatory compliance. + You must… more
- 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
- 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
- Fujifilm (Boston, MA)
- …Manager. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... skills, self-starter a must along with ability to maintain paperwork to FDA and company required standards. + Excellent analytical and communication skills with… more
- Takeda Pharmaceuticals (Boston, MA)
- …related experience. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing ... on patients worldwide. Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part of...lead as a member of a GRT + Primary FDA contact for projects of responsibility. + Accountable for… more
- J&J Family of Companies (Danvers, MA)
- …activities. + Strong understanding of design controls, risk management, and regulatory requirements ( FDA , ISO). + Exceptional project coordination skills, ... with demonstrated leadership in managing complex projects that span technical, regulatory , and operational domains. This role requires an inspirational and… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …drug products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global … more