- Fujifilm (Lexington, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... under their responsibility, in close collaboration with marketing, Quality and Regulatory team members and/or Affiliates and contract manufacturer employees involved… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …for industry applicable to the design, analysis of clinical trials and process for regulatory submissions across difference regions (ICH, FDA , EMA and others). + ... each project. + Leads strategic, scientific, and operational aspects of multiple drug development projects with a high level of technical and strategic independence… more
- Charles River Laboratories (Wilmington, MA)
- …We have proudly worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits ... worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- … drug listing and establishment registration activities. Ensure that FDA postings are current and accurate (DailyMed, NDC Directory, Establishment Directory, ... other scientific field. + 6-8 years of relevant experience in pharmaceutical regulatory /labeling environment and/or drug development + Knowledge of scientific… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …within the pharmaceutical, biotech, or CRO industry. + In-depth knowledge of ICH-GCP, FDA , EMA, and other global regulatory requirements related to clinical ... of clinical trial data and ensuring patient safety by verifying adherence to regulatory requirements and internal standards. As a key member of the Global Quality… 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 ... US/EU + Solid and Multiple experience in preparing and interacting with multiple regulatory agencies including FDA , EMA, and others + Multiple NDA/MAA submission… more
- Beth Israel Lahey Health (Burlington, MA)
- …knowledge of specific protocols. Implements study protocols in accordance with regulatory , departmental and institutional requirements. Uses the nursing process to ... trials research adhering to Research SOPs, GCP compliance and FDA regulations. 2) Functions as a mentor, resource and...study subjects and family on protocol, study interventions, study drug , etc.; acts as a liaison between study subjects… more
- Sanofi Group (Cambridge, MA)
- …project team and internal partners, such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, ... + Engage with health authorities (contribute to health authority submissions (such as new drug application) and timely response to regulatory reviews) + Serve as… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and ... in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role...patients. **Job Description** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream… more
- Sanofi Group (Cambridge, MA)
- …clinical part of regulatory documents, Common Technical Document for submission to regulatory bodies ( FDA , EMA, PMDA) and answers to questions from health ... + Clinical trial or pharmaceutical experience in ophthalmology + Knowledge of drug development, ocular gene therapy, regulatory strategy + Good networking… more