- Takeda Pharmaceuticals (Boston, MA)
- …the study, organize and prioritize programming activities including production and quality control of datasets and outputs while following internal standard ... (CRO) to ensure they meet programming milestones/timelines and high quality of programming deliverables; collaborate and communicate effectively with internal… more
- Integra LifeSciences (Braintree, MA)
- …A minimum of 2-4 years' experience in a medical device, pharmaceuticals, Quality /Regulatory Compliance , or other cGMP regulated product preferred environment. + ... Familiarity with application of FDA and/or ISO quality standards in a...presentations. + Experience with performing Microbiological assays in cGMP compliance lab and understanding of aseptic techniques. + Working… more
- Nanobiosym, Inc. (Cambridge, MA)
- …testing. + Support regulatory and quality processes with a focus on FDA and ISO 13485 compliance . Minimum Qualifications: + Master's Degree in Electrical ... engineering experience in product development environments. + Strong understanding of compliance standards in regulated industries (eg, FDA , ISO 13485).… more
- Integra LifeSciences (Braintree, MA)
- …using electronic document storage. + Minimum of 1-2 years' experience in a Quality Systems I Regulatory Compliance environment with a working knowledge ... preferably in the medical device, diagnostics or pharmaceutical industries. Familiarity with FDA regulations and ISO series of quality standards preferred. +… more
- Sumitomo Pharma (Boston, MA)
- …rigorous and innovative trial protocols. + Oversee clinical trial execution, ensuring quality , patient safety, and compliance with GCP standards. + Develop ... goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and… more
- Beth Israel Lahey Health (Boston, MA)
- …of patients for participation in multiple clinical trials, ensuring compliance with federal, state and institutional guidelines. Financial responsibilities including ... of adverse events and reports them according to the guidelines of the FDA , sponsoring drug accompany (if applicable) and the IRB. May interact with sponsors… more
- Rhythm Pharmaceuticals (Boston, MA)
- …and NDA/IND commitments + Act as an expert resource for eCTD submissions to FDA , ensuring compliance with internal and health authority standards + Support the ... of eCTD submission-ready documents, coordinating across functions, and ensuring quality , accuracy, and adherence to regulatory guidelines. Additionally, the… more
- CGI Technologies and Solutions, Inc. (Burlington, MA)
- …activities for the organization's Quality Management Systems (QMS), ensuring compliance with pharmaceutical regulatory requirements ( FDA , EMA, etc.). * ... and QA Lead will be responsible for managing the validation activities, quality assurance processes, and regulatory compliance for pharmaceutical projects. This… more
- Catalent Pharma Solutions (Chelsea, MA)
- …needs.** **Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, ... assessments and GMP evaluations of control systems to ensure they meet FDA requirements. Prepares standard operating procedures for new and existing control… more
- Chiesi (Boston, MA)
- …than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the ... get content approved to support business needs + Ensures regulatory compliance while effectively managing business risks + Understands global promotional strategies… more
Recent Jobs
-
Market Access Marketing & Non-Personal Promotions (NPP) Lead, IZERVAY
- Astellas Pharma (San Francisco, CA)