- Eisai, Inc (Nutley, NJ)
- …management concepts. Must have a detailed knowledge of domestic and international regulatory requirements (including ICH and GCP guidelines) Expertise ... TMF vision and transformation initiative and is compliant with ICH-GCP and regulatory requirements . Th is role also provides direction, leadership and training… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …drug or biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance ... Reviews and assesses Corrective and Preventive Action Reports Participates in Regulatory Inspections Other duties as assigned Performs all job duties and… more
- DivIHN Integration Inc (Atlanta, GA)
- …and/or presentation. Ensure compliance of clinical documents with national and international regulatory requirements and guidelines and Client procedures (as ... Medical Advanced Surgery will write and edit clinical documents to support regulatory submissions for relevant products. The ideal candidates must have a scientific… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …robust regulatory strategies required Experience interacting directly with regulatory authorities on an international scale Experience preparing teams ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You… more
- Insmed Incorporated (San Diego, CA)
- …of clinical research (Phase 1-3)Knowledge of ICH-GCP and FDA regulatory guidelinesDomestic and/or International travel required 20%Travel RequirementsDomestic ... & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor activities and data.… more
- Uline (Pleasant Prairie, WI)
- International Trade Compliance InternshipPaid Internship - Summer 2025 Corporate Headquarters12575 Uline Drive, Pleasant Prairie, WI 53158 Ready to boost your skills ... and kick-start your career? Join Uline as a 2025 International Trade Compliance Intern! You'll get hands-on experience and work with professionals at a company that… more
- Amerant Bank (Coral Gables, FL)
- The Senior International Relationship Manager (SRM) is responsible for managing and retaining a book of business of High Net Worth and Ultra High Net Worth personal, ... good standing by adhering to policies and procedures, including completing firm and regulatory trainings, and by raising awareness of any issues that may affect the… more
- Careers Integrated Resources Inc (Atlanta, GA)
- Job Title: Regulatory Affairs Specialist - II Job Location: 100% Remote Job Duration: 3 Months+ (Possible extension) Job Description: . The Regulatory Affairs ... business unit in meeting global registration requirements. . As a regulatory process expert supporting global registrations the candidate interprets federal/state/… more
- International Dairy Queen, Inc. (Minneapolis, MN)
- …one of the world's best known and loved brands. Based in Minneapolis, MN, International Dairy Queen Inc., (IDQ), is the parent company of American Dairy Queen ... complaints, assistance with vendor vetting process, and assistance with regulatory issues including withdraws, new regulations, etc. Support internal/external… more
- Indotronix International Corporation (Elk River, MN)
- …and/or communication test results. Help develop food/feed safety, quality and regulatory culture collaborating cross-functionally to build, maintain and improve an ... effective food safety, quality and regulatory culture. Run calibration checks, preventive maintenance tasks, and simple repair to analytical instrumentation,… more
- Indotronix International Corporation (Irvine, CA)
- …interface with RF engineers, RE specialists, PM's, Construction, Network Assurance, Regulatory specialists, Landlords and vendors. You will need to work ... cross-functionally to troubleshoot and resolve property issues as they arise. Must have prior Property Management and Real Estate Contracts experience. Good customer service and organizational skills required. Must have intermediate to advanced computer… more
- Dunhill Professional Search (Rapid City, SD)
- …equipment.Understanding of regulatory agencies' requirements, industry regulatory requirements and International Standard Organization standards.Familiarity ... with the setup and application of test equipment.Ability to read, analyze, and interpret technical literature, schematics, and drawings.Ability to obtain a Public Trust clearanceLevels: Level I - A minimum of one year of hospital or healthcare experience… more
- The George Washington University (Washington, DC)
- …privacy and technology law. Familiarity with major federal and state regulatory agencies, other national/ international governmental or non-profit agencies, and ... a new recruitment plan and work with Graduate and International Programs to initially create an LLM and MSL...and Technology Law. Then work with the Graduate and International Programs Office to recruit students for these new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring CMC… more
- Tris Pharma (Monmouth Junction, NJ)
- …that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in ... the US, have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global ... of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the Quality Manual. Responsible ... adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for the creation and review Quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents ... ensuring that outsourced obligations are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate systems, processes… more
- Tris Pharma (Monmouth Junction, NJ)
- …that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in ... the US, have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic… more
- Aequor (Providence, RI)
- …diverse functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory , Quality Assurance, Quality Engineering, International Quality and ... data and may serve as a primary author on regulatory filings and directly participate in and support site-based...analytical techniques General knowledge of cGMP and US and international filing regulations pertaining to the manufacture and testing… more
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