- Amgen (Cambridge, MA)
- …technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. + May lead and develop a small group of scientists. ... stability testing. + Familiarity with USP monographs and chapters, and ICH/ FDA guidance documents related to analytical method transfer and validation, impurities,… more
- Biomat USA, Inc. (Worcester, MA)
- …Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance. . Maintains oversight of center training program by ensuring ... . Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and… more
- Takeda Pharmaceuticals (Boston, MA)
- …for clinical deviation management, and Serious Breaches investigation and reporting to regulatory agencies. + Act as strategic partner to Clinical Program Quality ... Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA , EU, MHRA, PMDA and ICH. + Experience must include successful… more
- Sanofi Group (Cambridge, MA)
- …a manner that advances the company's strategy while addressing legal and regulatory risks and preserving and protecting the company's integrity and reputation. The ... highly valued. Ability to identify potential legal issues (focusing on promotional matters, regulatory issues, and fraud and abuse) as well as proposed solutions to… more
- BioLife Plasma Services (Boston, MA)
- …gain hands-on experience in operational production, including financial, regulatory , administrative, marketing, quality, facilities, and people management. Gain ... customer service by assisting with production tasks while maintaining strict regulatory compliance and safety standards. + **Develop Leadership and Employee… more
- Amgen (Cambridge, MA)
- …protocols, reports, analytical method descriptions and analytical CMC sections in regulatory documents + Lead project teams and/or project sub-teams to meet ... and International Conference on Harmonization (ICH) / Food & Drug Administration ( FDA ) mentorship documents related to analytical method transfer and validation. +… more
- Teleflex (Chelmsford, MA)
- …risk management activities for supported products * Partner with R&D, Marketing, Regulatory Affairs, and Operations to support activities in product and process ... the NC and CAPA systems as needed to structure activities. * Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries. * Partner with… more
- 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 ... development strategies for research projects + Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project… more
- Children's Hospital Boston (Boston, MA)
- …supporting staff development, and ensuring high standards of care and regulatory compliance within the department and Feeding Preparation Center. Key ... accreditation requirements, professional credentialing, and state licensure requirements. Applies regulatory knowledge of agencies including The Joint Commission, DPH,… more
- Charles River Laboratories (Shrewsbury, MA)
- …of Pharmacology processes, templates for protocols, and reports. Provide scientific and regulatory advice to the Pharmacology group and interact with colleagues in ... with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling… more