- Aequor (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
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager , Global Regulatory Labeling Strategy where you will be ... and/or related experience. + Knowledge of US and EU product labeling regulatory requirements and guidelines. + Familiarity with US and/or EU regulatory… more
- United Therapeutics (Research Triangle Park, NC)
- …back of your hand - you might be exactly who we're looking for. The Regulatory Affairs Manager will manage and lead the preparation, compilation, and review of ... regulatory submissions and related CMC and labeling ...for assigned projects. This role will collaborate with the manager , project teams, and functional area representatives to devise… more
- Boehringer Ingelheim (Ridgefield, CT)
- …products and products in development * Provide analysis, advice and guidance on US regulatory labeling topics with a focus on package labeling compliance ... and new development * Research information on regulatory labeling standards and departmental policies. **Requirements** * Doctor of Pharmacy degree from an… more
- Medtronic (Irvine, CA)
- …of medical device experience, including knowledge of the US and International regulatory requirements for Advertising & Promotional labeling , or an advanced ... to ensure that it meets all medical, legal, and regulatory (MLR) process requirements. + Facilitate review meetings online...+ Support the preparation of US and International promotional labeling material, including the creation of a claims matrix… more
- Boehringer Ingelheim (Ridgefield, CT)
- … for NCEs/NBEs and labeling supplements, in conjunction with the assigned RA Labeling Content Manager and Product Manager in the RA Product Groups. ... labeling initiatives in compliance with Corporate and local regulatory requirements. The AD, DRA Product Labeling ...to be able to properly understand the implications of labeling decisions throughout the business Manager : +… more
- Amgen (Washington, DC)
- …and works with cross functional teams to ensure that the execution of global regulatory labeling plans are aligned with global regulatory strategies. + ... you are meant to be in this meaningful role. ** Labeling Strategist, Manager ** The purpose of the...layout templates for use in HF studies + Represents labeling on product-specific global regulatory teams +… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- …Variable (On-Demand) software with ERP/WMS systems (eg, SAP, Oracle, etc.). + Ensure regulatory compliance with labeling standards such as GS1, FDA, and UDI. ... year(s). + Implement and configure Variable (On-Demand) software for efficient labeling processes. + Automate labeling workflows using Variable (On-Demand)… more
- Danaher Corporation (Miami, FL)
- …Intern will gain hands-on experience and exposure in the critical area of regulatory labeling within the medical device and Life Sciences industry. Interns ... projects to meet FDA, EU, IVDR, ISO, CLP/GHS, and other countries' regulatory requirements. . Support the management of labeling change control processes,… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …components, randomization file and label text). + Generates internal packaging and labeling production orders in accordance with the clinical trial design and all ... relevant regulatory requirements for assigned projects. + Responsible for the...teams in various areas. + Manage external packaging and labeling activities + Identifies opportunities for improving business processes… more
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