- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical ... having a wide range of experience and a complete understanding of Regulatory Labeling roles and responsibilities Demonstrates full knowledge of industry… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Manager , Regulatory Affairs Labeling position will provide ... Regulatory support for global labeling projects. Under the direction of the labeling leadership, the manager will develop, review and revise labeling … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …product launch. This individual also supports the systems and processes by which regulatory labeling items are created, approved submitted and maintained for ... Participates on cross-functional teams focused on the planning and execution of regulatory labeling operations. This includes anticipating labeling … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …designs or US labels regarding feasibility of promoting potential data/claims with manager oversight Participate/assist in US labeling negotiations as necessary. ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight travel ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Chiesi (Cary, NC)
- Global Regulatory Affairs Labeling & Promotional Manager Date: Jan 23, 2025 Department: Global Regulatory Affairs Job Type: Direct Employee Team: R&D, ... Pharmacovigilance & Regulatory Affairs Contract Type: Permanent Location: Cary, NC, US...internal company procedures and business objectives. Responsible for the regulatory review of advertising and promotional materials for products… more
- Takeda Pharmaceuticals (Columbus, OH)
- …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
- Boehringer Ingelheim (Ridgefield, CT)
- … revision. + Labeling Submissions to FDA - Coordinate preparation of regulatory labeling documents, for example, SPL, MS Word files, Artwork needed for ... management with excellent planning and organization. + Demonstrated knowledge of regulatory labeling and compliance requirements, including technology trends. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …including post-GLOC (Global Labeling Oversight Committee) endorsement. + Understand the labeling regulatory strategy on the Global Regulatory Team (GRT) ... + Assist in preparation, formatting and QC check of Labeling Documents (Company Core Data Sheet (CCDS), USPI and...to ensure that regulatory labeling requirements are met for assigned products. + Manage… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Manager , Regulatory Affairs Labeling position will provide ... Regulatory support for global labeling projects. Under the direction of the labeling leadership, the manager will develop, review and revise labeling … more
- Boehringer Ingelheim (Ridgefield, CT)
- …Under supervision, the Fellow will: * Provide analysis, advice and guidance on US regulatory labeling strategies. * Research information on regulatory ... Regulatory Expertise: The Fellow will develop basic regulatory labeling expertise/knowledge in one or more...supplements initiated by BI, in conjunction with RA Product Labeling Management and the assigned RA Product Manager… more
- Actalent (Round Lake, IL)
- Job Title: Regulatory Labeling Project Leader IIJob Description Provide analytical support to the Product Authentication and Labeling organization under ... status reports. Act as a liaison between the project manager and label team to monitor progress and ensure...+ BS Degree + 3-5 years of experience with Regulatory Labeling in Medical Devices + Proficient… more
- Integra LifeSciences (Princeton, NJ)
- … compliance, and cost management/process efficiency objectives. The Labeling Associate will collaborate with cross-functional teams, including Marketing, ... pathways to advance patient outcomes and set new standards of care. The Labeling Associate will assist with the execution and implementation of medical device … more
- Integra LifeSciences (Princeton, NJ)
- …to advance patient outcomes and set new standards of care. The Labeling Associate - Design is responsible for creating, reviewing, approving, and maintaining ... finished goods labeling artwork and templates. This role requires an understanding...execution of end-to-end label implementation. Functional understanding of regional regulatory requirements is essential, ensuring compliance with FDA, MDR,… more
- Takeda Pharmaceuticals (Columbus, OH)
- … regulatory and/or related experience. + Knowledge of US and EU IFU product labeling regulatory requirements and guidelines. + Familiarity with US and/or EU ... therapies to patients worldwide. Join Takeda as the Senior Manager , Global Labeling Devices. You will be...standards and guidelines. Serve as the expert for device labeling on the global Regulatory Affairs (RA)… more
- J&J Family of Companies (Raritan, NJ)
- Johnson & Johnson is recruiting for a Manager , Global Labeling Operations to be located in Raritan, NJ, Titusville, NJ, or Horsham, PA. At Johnson & Johnson, we ... for labeling under the responsibility of Global Labeling Operations, including : + Provision of Regulatory... Labeling Operations, including : + Provision of Regulatory guidance on the development of US packaging text… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …the technical aspects of the CGMP's as they relate to product packaging and labeling . Applies this knowledge to day-to-day packaging and labeling activities that ... Supervises union staff in all aspects of packaging and labeling of clinical supplies. + Print clinical labels utilizing...is required. + Strong working knowledge of cGMP's and regulatory (ie, FDA, EU, OSHA, etc.) requirements and their… more
- Danaher Corporation (Fargo, ND)
- … Manager , Operational QA, responsible for Developing and implementing labeling processes and procedures and collaborating with cross-functional teams, including ... Clients, Regulatory Affairs, and Marketing, to develop labeling strategies that align with regulatory requirements and company branding. In this role, you… more
- American Red Cross (Nashville, TN)
- …important concerns and opinions. **_WHAT YOU NEED TO KNOW:_** As a Quarantine and Labeling Technician, you will perform final product labeling of all blood ... and procedures. + Receive and review test results, run labeling program and processes. + May irradiate/x-ray of blood...+ Minimum 2 years of related experience in a regulatory , laboratory, or manufacturing environment or equivalent combination of… more
- Chobani (New York, NY)
- …advertising, and claim substantiation for North American business Manage labeling manager direct report(s) to ensure regulatory compliance of products and ... Summary The Senior Manager , Regulatory Compliance & Nutrition will...regulatory compliance. Demonstrated experience in working on large-scale regulatory projects involving formulas, ingredients and labeling .… more
