- Arvinas (New Haven, CT)
- …patients with solid tumors with KRAS G12D mutations. On August 8 th 2025, the US Food and Drug Administration (FDA) accepted the New Drug Application (NDA) ... detailed knowledge of the activities and procedures involved in clinical drug development. The Clinical Scientist will collaborate with Clinical Operations,… more
- The Clorox Company (Willowbrook, IL)
- …cosmetic and personal care space. + Strong knowledge of FDA regulations [e.g., The Food Drug and Cosmetic Act (FD&C Act), Modernization of Cosmetics Regulation ... robust compliance program for our personal care and over-the-counter (OTC) drug products. This role independently leads regulatory activities, ensuring compliance… more
- Eisai, Inc (Cincinnati, OH)
- …laws and regulations impacting the pharmaceutical industry (eg, PhRMA Code; Federal Food , Drug , Cosmetic Act; Anti-Kickback Statute; False Claims Act, OIG/DOJ ... Guidance; Foreign Corrupt Practices Act; and federal and state transparency and disclosure laws) preferred.Demonstrated skills at building and maintaining professional relationships with key customers and others in the customer influence network,… more
- PRIDE Industries (Roseville, CA)
- …Program (NOP), California Health and Safety Code, Division 104, Part 5 - Sherman Food , Drug and Cosmetic Law: 2008, and FDA's Quality System Regulations, ... including at least three years in a supervisory position; - Knowledge and training in Food Safety (HACCP) and Food Protection programs, National Organic… more
- Tris Pharma (Monmouth Junction, NJ)
- …and procedures throughout the organization. Ensures compliance with all current GxPs, Food and Drug Administration (FDA), Drug Enforcement Administration ... (DEA), and Occupational Health and Safety Administration (OSHA) regulations, as well as all applicable company compliance guidelines, standards and objectives Leads and/or oversees functions (ie, purchasing/procurement, warehousing, logistics, etc.) to ensure… more
- PRIDE Industries (Roseville, CA)
- …Program (NOP), California Health and Safety Code, Division 104, Part 5 - Sherman Food , Drug and Cosmetic Law: 2008, and FDA's Quality System Regulations, ... developmental disabilities and/or physical challenges, preferred; - Knowledge and training in Food Safety (HACCP) and Food Protection programs, National Organic… more
- Eisai, Inc (Atlanta, GA)
- …laws and regulations impacting the pharmaceutical industry (eg, PhRMA Code; Federal Food , Drug , Cosmetic Act; Anti-Kickback Statute; False Claims Act, OIG/DOJ ... Guidance; Foreign Corrupt Practices Act; and federal and state transparency and disclosure laws).Experience networking, establishing, and maintaining strong business relationships across multidisciplinary matrix teams within Eisai.Sr. Area Business Leader-… more
- Integra LifeSciences (Plainsboro, NJ)
- …and distribution of medical products is in compliance with corporate policies, US Food and Drug Administration regulations, ISO 9001, ISO 13485, the Medical ... + Maintains a thorough understanding of the following regulations and guidelines: US Food and Drug Administration (FDA) regulations, ISO 9001, ISO 13485, Medical… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff ', the FDA 2022 Guidance, 'Content ... in Medical Device Marketing Submissions Draft Guidance for Industry and Food and Drug Administration Staff', Quality System Regulation (QSR), ISO 13485, 14971,… more
- Tris Pharma (Monmouth Junction, NJ)
- …or skills needed and/or licenses or certificates preferred: Experience working with Food and Drug Administration (FDA), current Good Laboratory Practices ... (cGLPs), cGMPs, SOPs and regulatory rules, regulations and guidelines Proficiency with Empower software Ability and/or experience training and mentoring lower level chemists Experience with wet chemistry and chemistry related to sampling methods, quality… more
- Tris Pharma (Monmouth Junction, NJ)
- …accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record ... specifications. The incumbent creates and tracks work orders, assists in resolution of material shortages, material transfer and replenishment strategy execution ensuring product availability while minimizing excess inventory.Carries out responsibilities in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and ... International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with… more
- Cipla (Hauppauge, NY)
- …Good Manufacturing Practices (cGMP), Packaging Area Standard Operating Procedures and Food and Drug Administration (FDA) regulations Ability to communicate ... effectively and clearly, both written and verbally in English. Comply with safety and quality regulatory standards when packaging products.Ensure products are packaged in accordance with packaging time standards. Flexible and Adaptable: Copes with ambiguity,… more
- Tris Pharma (Monmouth Junction, NJ)
- …accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record ... specifications. She/he operates and maintains various pharmaceutical packaging equipment as assigned, and thoroughly and accurately documents all activities to ensure compliance with regulatory guidelines.ESSENTIAL FUNCTIONS Primary… more
- Parexel (Little Rock, AR)
- …when applicable **Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + ... adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE… more
- BeOne Medicines (Emeryville, CA)
- …conferences, press releases, and investor presentations. + Advise and train on the Food , Drug and Cosmetic Act, FDA guidance documents, industry codes and ... standards (eg, PhRMA, ICMJE, ACCME), and other laws and regulations applicable to the development and commercialization of pharmaceutical products. + Assist with the development and implementation of policies and procedures related to healthcare compliance in… more
- Luke Staffing (Portsmouth, VA)
- …Improvement Amendments (CLIA), to include screening tests and other tests cleared by the Food and Drug Administration (FDA). + Prepare specimens for transport in ... accordance with Medical Treatment Facility (MTF) policy. + Perform precise and accurate laboratory testing according to established laboratory procedures. + Participate in peer review and performance improvement activities. + Practice aseptic techniques as… more
- Integra LifeSciences (Plainsboro, NJ)
- …associate will perform all required duties in compliance with company policies, US Food and Drug Administration and DOT/IATA, ISO 13485, and other applicable ... regulatory agencies. **SUPERVISION RECEIVED** Under direct supervision of the Warehouse Supervisor **This role is a Monday - Friday 1st Shift (8am - 4:30pm** ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this job successfully, an individual must be able to… more
- Integra LifeSciences (Braintree, MA)
- …manufactured sub-assemblies and final product. Must have working knowledge of US Food and Drug Administration regulations, ISO 13485, and other applicable ... regulatory agencies as they pertain to laboratory testing. **Primary responsibilities are to:** + Responsible for performing Microbiological testing such as Bioburden, Endotoxin, Gram staining, Growth promotion testing, TOC & Conductivity testing, sending… more
- Integra LifeSciences (Braintree, MA)
- …manufactured sub-assemblies and final product. Must have working knowledge of US Food and Drug Administration regulations, ISO 13485, and other applicable ... regulatory agencies as they pertain to laboratory testing. + Responsible for performing Analytical testing such as TOC, Conductivity, Osmometry and pH testing. + Perform mechanical testing, DSC (Differential scanning calorimeter) and DBT (Burst testing). +… more
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