- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Merck & Co. (Rahway, NJ)
- …of clinical trial s .- GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The GCS ... arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact… more
- Merck & Co. (Rahway, NJ)
- …of clinical trial s .- GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The GCS ... the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities… more
- Eisai, Inc (Nutley, NJ)
- …speakers and related aspects of speaker programsCollaborate with Promotional Program Manager for speaker usage and issuesOffer feedback on nominating new speakers ... on the cutting edge of data readouts (consistent with FDA-approved labeling ), medical congress meeting outputs and podium & symposia presentations.Identify best… more
- Katalyst HealthCares and Life Sciences (Elk Grove Village, IL)
- Responsibilities: The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and ... Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes. This person… more
- Katalyst HealthCares and Life Sciences (Tarrytown, NY)
- …teamwork abilities. Active participation in Lesson learned process, derived from regulatory correspondences. Support TA Labeling team, when required. Participate ... submission, and monitoring of PLAIR activities, prior to new product launch. Manage regulatory correspondence mainly to CDER, FDA, User fee staff, drug listing and… more
- Prestige Recruiting Firm (Clearwater, FL)
- Pre-Market Regulatory Affairs Manager Remote Why Join Us: Be part of an established leader in the aesthetics industry with exciting new innovations Help shape ... and a supportive company culture About the Role: We're seeking an experienced Pre-Market Regulatory Affairs Manager to drive global regulatory strategy and… more
- Ascendis Pharma (Princeton, NJ)
- …to working together as one team to achieve extraordinary results. The Senior Manager Regulatory Affairs, Advertising and Promotion will be an internal expert ... promotion of prescription drug and biologic products. The Senior Manager Regulatory Affairs, Advertising and Promotion is... impact of new campaign concepts, target, or product labeling , and to provide strategic regulatory guidance… more
- Pernod Ricard (Louisville, KY)
- …internal brand co. regulatory and operations teams to ensure liquid and labeling compliance (eg, GRAS) for the US, Canada and export markets. Build a strong ... the position. Purpose of the Position To provide strong and clear strategic regulatory leadership for all North American innovations and NPDs. This role will… more
- Kyowa Kirin North America (Princeton, NJ)
- …and system integrations is a plus. IRT experience required. Understanding of regulatory requirements impacting packaging, labeling , and distribution of clinical ... Summary of Job: Responsible for managing clinical trial material Packaging, Labeling , distribution, and storage according to local and global regulations. Essential… more
- IntePros (Audubon, PA)
- … regulatory files. Perform literature searches and extract information to support regulatory submissions. Assist with review of labeling and clinical reports ... for regulatory compliance. Assist in the coordination of product labeling revisions for marketing outside the United States. File Certificates to Foreign… more
- National Guard Employment Network (Phoenix, AZ)
- …us and transform the lives of patients while transforming your career. Specialty Account Manager , Referral Live What you will do Let's do this. Let's change the ... treatment. Regularly communicate progress with SAM/ASD. Promotes KRYSTEXXA(R) within approved labeling in a comprehensive, fair, and ethical manner that is… more
- Taylor Strategy Partners (Boston, MA)
- …City. About This Role Our client is seeking a Specialty Account Manager (SAM) to execute commercial activities for assigned geographies, establish relationships with ... & annual goals established by commercial leadership Promote within our approved labeling in a comprehensive, fair, and ethical manner that is consistent with… more
- Harveys Retail Stores (Winter Haven, FL)
- …full, authentic selves. Read our Belonging, Inclusion and Diversity Statement here. Grocery Manager Job Purpose Job Summary Assists in the management of the daily ... handling practices, sanitation and productivity are maintained. Adheres to all regulatory compliance requirements pertaining to food safety, United States Department… more
- VetJobs (Fort Lauderdale, FL)
- …alongside other innovative, driven professionals in this meaningful role. Specialty Account Manager , Endocrinology Live What you will do Let's do this. Let's change ... sales, and performing total territory account management. The Specialty Account Manager is responsible for providing account management support to accounts within… more
- LanceSoft (Tampa, FL)
- …that performs one or more packaging functions, such as filling, marking, labeling , tying, packing, or wrapping containers. 1-3 Years Experience Summary Execute ... assembly instructions per Batch Record requirements for Packaging and Labeling processes in compliance with cGMP guidelines. This will require on time and neat… more
- BioSpace (Detroit, MI)
- …Join us and transform the lives of patients while transforming your career. Key Account Manager - Tavneos Detroit, MI What you will do Lets do this. Lets change the ... world. We are seeking a Rare Disease Key Account Manager (RD KAM) to implement commercial activities for the...Account Executives in shared accounts. Promote Tavneos within approved labeling in a comprehensive, fair and ethical manner that… more
- Covenant Health (Oak Ridge, TN)
- …records in a timely and orderly fashion for monthly review by Laboratory Manager and periodic view by regulatory agencies. Reconstitutes and/or properly mixes ... specimens. Properly uses the referring hospital's Blood Bank identification system when labeling Blood Bank specimens. Places Blood Bank armband on patient at… more
- CH Guenther & Son LLC (Elk Grove, CA)
- …safety initiatives to promote a culture of safety. Ensure compliance with regulatory requirements (SQF, GMP, HACCP, OSHA) and company policies and trainings related ... and that the product meets the quality requirements. Communicates with Warehouse Manager / Leads to notify discrepancies with any orders. Ensures that all paperwork… more
- Dallas Baptist University (Dallas, TX)
- …of Conduct. Click here to read GENERAL OBJECTIVES: The Science Safety and Lab Manager is tasked with managing all laboratory operations within the College of Natural ... local rules concerning occupational safety including training, documentation, purchasing, storage, labeling , data of all chemicals and MSDS sheets, proper protocol… more
