- 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 (Philadelphia, PA)
- …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
- BeOne Medicines (Emeryville, CA)
- …driving strategies, programs, and external engagement + Understanding of the prescription drug regulatory environment and clinical trial submission process in ... representative patient enrollment. This role collaborates across Clinical Operations, Regulatory , Development, and corporate functions to embed diversity into study… 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
- The Clorox Company (Durham, NC)
- …a robust compliance program for our personal care and over-the-counter (OTC) drug products. This role independently leads regulatory activities, ensuring ... OTC drug regulations/monographs. + Proven ability to lead project regulatory strategies and influence cross-functional teams. + Excellent written and verbal… more
- Parexel (Montgomery, AL)
- …and/or drug -device combination products are a plus) - Support regulatory leads in developing contingency plans for CMC-related scenarios - Represent CMC ... FDA, EMA, and Health Canada (IND, NDA, DMF) - In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small… 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
- Stony Brook University (Stony Brook, NY)
- …a minimum of three (3) professional references. + Successfully complete a 4 panel drug screen * + Meet Regulatory Requirements for pre employment screenings. + ... and timely reporting of patient results and compliance with all regulatory standards. Qualified candidates will demonstrate superior patient care and possess… more
- Stony Brook University (Stony Brook, NY)
- …a minimum of three (3) professional references. + Successfully complete a 4 panel drug screen * + Meet Regulatory Requirements for pre employment screenings. + ... reporting quality control and auditing. The position requires compliance with regulatory agencies, ie NYSDOH, CAP, Joint Commission and University Hospital and… 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
- Stony Brook University (Stony Brook, NY)
- …a minimum of three (3) professional references. + Successfully complete a 4-panel drug screen * + Meet Regulatory Requirements for pre-employment screenings. + ... senior Clinical Laboratory Technologist. + The new Incumbent will assists in the regulatory mandated inventory control process by tracking the Core Lab reagent lot… more
- Stony Brook University (Stony Brook, NY)
- …a minimum of three (3) professional references. + Successfully complete a 4 panel drug screen * + Meet Regulatory Requirements for pre employment screenings. + ... as well as keeping the hospital compliant with the many regulatory agencies, maintaining patient safety through correct patient identification practices and… more
- Stony Brook University (Stony Brook, NY)
- …a minimum of three (3) professional references. + Successfully complete a 4 panel drug screen * + Meet Regulatory Requirements for pre employment screenings. + ... System_ WellSky Transfusion to conform to the changing operational and regulatory requirements of the department. Inclusive of database changes, test development… more
- Stony Brook University (Stony Brook, NY)
- …a minimum of three (3) professional references. + Successfully complete a 4 panel drug screen * + Meet Regulatory Requirements for pre employment screenings. + ... II. * Communicate effectively with Main Laboratory, Point of Care Dept., regulatory agencies and vendor technicians * Assist in teaching respiratory therapists,… more
- Stony Brook University (Stony Brook, NY)
- …a minimum of three (3) professional references. + Successfully complete a 4 panel drug screen * + Meet Regulatory Requirements for pre employment screenings. + ... Offsite Hospital Outpatient Registrar reviews registrations for completeness, obtains regulatory consents, and ensures financial clearance is complete, collecting… more
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