- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory intelligence. + Previous interactions with FDA or other health authority ... The Associate Director of Regulatory Intelligence leads the collection and dissemination of...and device development process, laws, regulations, and guidelines from FDA , EMA, PMDA, ICH, etc. + General knowledge of… more
- Chiesi (Boston, MA)
- …for the better. Who we are looking for Purpose Responsible for the regulatory review and submission of advertising and promotional materials for multiple Chiesi ... to existing labeling, and submission of labeling information to regulatory authorities in the United States and Canada. Main...and by attendance of major FDLI, DIA and other industry/ FDA meetings. + Ensures that changes in US Prescribing… more
- Bausch + Lomb (Boston, MA)
- …solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies. + Monitors FDA and FTC ... abreast of market promotional and advertising strategies. + Provide regulatory support as needed for FDA warning...+ Provide regulatory support as needed for FDA warning and untitled letters, FTC letters, and direct… more
- Insight Global (Westborough, MA)
- …Pipelines), and others as applicable. The role ensures these tools align with regulatory requirements (eg, FDA , IEC 62304, ISO 13485) and supports system ... knowledge of compliance frameworks relevant to SaMD (IEC 62304, ISO 13485, FDA CFR Part 11). Excellent communication, problem-solving, and documentation skills. *… more
- Abbott (Burlington, MA)
- …system improvement activities. + Comply with US Food and Drug Administration ( FDA ) regulations, EUMDR, and other regulatory requirements and Abbott policies, ... or an equivalent combination of education and experience. + Knowledge of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304),… more
- ThermoFisher Scientific (Plainville, MA)
- …2-3 years experience leading teams in a fast-paced environment required. + Experience with regulatory inspections from the FDA , EMA, Health Canada, or other ... and drive efficiency throughout the organization. + Support internal, external, and regulatory inspections as needed. + Hire and develop employees within the… more
- Parexel (Boston, MA)
- …and evaluating clinical sections of regulatory applications. + Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master ... drug development-we help shape it. As a **Senior/Vice President, Technical** on our Regulatory Strategy (RS) team, you'll be at the forefront of innovation, guiding… more
- Sumitomo Pharma (Boston, MA)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global ... Regulatory Affairs (GRA) team based in the US. He/She...to achieve results + Understanding of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical research… more
- Rhythm Pharmaceuticals (Boston, MA)
- …to overcome barriers, together. Opportunity Overview In the Associate Director, Regulatory Affairs role, you will be responsible for ensuring the development ... and delivery of science-based, solution-oriented and internally aligned regulatory strategies for the program(s) under your accountability. You will lead the … more
- Cytel (Cambridge, MA)
- …Medidata Rave, Oracle Inform, Veeva, or similar). + Excellent understanding of ICH-GCP, FDA , EMA, and other global regulatory guidelines. + Strong attention to ... individual brings advanced knowledge of medical terminology, clinical trial processes, regulatory requirements, and coding best practices. The Senior Medical Coder… more