- Formation Bio (New York, NY)
- …assesses regulatory risks associated with product development for Formation Bio's drug assets. Represents the Regulatory function on asset development teams ... supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC guidance around drug development and manufacturing/supply processes… more
- Merck & Co. (Rahway, NJ)
- …oncology, diabetes, respiratory & immunology, cardiology, pain & inflammation, reproduction, drug delivery or biotechnologyKnowledge of regulatory aspects of ... Job DescriptionThe Principal Scientist, Drug Discovery in our Research and Development Department...of 8 years industry or pharmaceutical research experience in drug discovery or preclinical research with a focus on… more
- Eisai, Inc (Boston, MA)
- …including but not limited to Emerging MarketsAdvance experience with the drug development process and eCTD regulatory submission standardsExpert understanding ... experience creating timelines for the development and submission of drug filings to regulatory health authoritiesExcellent organizational skills… more
- Merck & Co. (North Wales, PA)
- …and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development ... in a clinical trial environment. Requirements: Experience in US and/or worldwide drug or vaccine regulatory application submission including the development of… more
- Merck & Co. (Rahway, NJ)
- …that include coordinating the activities of a programming team.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (North Wales, PA)
- …reporting processes (SOPs) and software development life-cycle (SDLC)US and/or worldwide drug or vaccine regulatory application submission experience including ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- …materials to foster a culture of operational excellence Ensure processes align with regulatory requirements for medical device and drug combination products (eg, ... ISO 14971) Collaborate with cross-function teams to improve processes related to device- drug integration. Partner with Quality and Regulatory teams to ensure… more
- Merck & Co. (South San Francisco, CA)
- …for planning and management of an important inflection point in the drug development process, working closely with scientific, regulatory , statistical, and ... clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and… more
- Eisai, Inc (Nutley, NJ)
- …broad pharmaceutical industry experience, including 8 years of direct Regulatory Affairs experience with new/innovative drug registration strategy/submissions. ... we want to hear from you. The Director, Global Regulatory , Growth Markets will be responsible for providing ...in both CTD format and non-CTD format.Experience of the Drug Development process and working with cross functional international/global… more
- Insmed Incorporated (NJ)
- …plusSignificant experience in interactions with FDA, EMA, and other global regulatory agenciesDeep understanding of the drug development processHighly organized ... for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global … more
