- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. We are currently seeking a Global Regulatory Affairs Labeling Operations Intern for Summer ... Position Summary:We are seeking a detail-oriented and tech-savvy student to join our Global Regulatory Affairs Labeling Operations team as an intern.The … more
- Merck & Co. (Rahway, NJ)
- …required) - Functional Area: Regulatory Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) - The ... user requirements, workflows, and metadata standards. Ensure compliance with global regulatory standards and internal SOPs for... Affairs Management, Regulatory Compliance, Regulatory Documents, Regulatory Labeling , … more
- Unknown (Gaithersburg, MD)
- Vice President, Regulatory Affairs About the Company Thriving T-cell receptor biotechnology company Industry Biotechnology Type Public Company Founded 2008 ... disease oncology immtacs immune system hiring biologics autoimmune jobs scientists regulatory affairs and cmc biotechnology cancer infectious diseases autoimmune… more
- AbbVie (Irvine, CA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Strategic Global Labeling Manager in Regulatory Affairs is responsible for developing ... and delivering patient-centered global product labeling for the safe and effective use of AbbVie...process the labeling in accordance with internal labeling procedures. + Maintain documentation within regulatory … more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …Preferred **Knowledge and skills** + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and industry ... Drive Labeling Strategy, in-line with overall global regulatory strategy, by providing labeling expertise for Company Core Data Sheet (CCDS), USPI and… more
- Parexel (Columbia, SC)
- …of the pharmaceutical industry drug development process and willingness to learn global labeling regulatory requirements and industry practice + ... you'll be the go-to expert for global labeling , working side-by-side with client teams across Regulatory... labeling , working side-by-side with client teams across Regulatory Affairs , Technical Operations, Safety, and Commercial.… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Regulatory Affairs Labeling Operations Fellowship is designed to provide pharmacists with exposure to regulatory requirements for US ... Affairs and across functions, as a US regulatory package labeling advocate to achieve common...labeling negotiations, on assigned projects/products. * Interact with Global Labeling Artwork Management to ensure high… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible ... **Escalation Process and Stakeholder Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible ... Escalation Process and Stakeholder Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and… more
- Chiesi (Boston, MA)
- …Main Responsibilities + Promotional Material/External Communications Responsibilities: + Work in the Global Rare Diseases, Regulatory Affairs Ad Promo ... Chiesi Global Rare Disease procedures for the regulatory aspects of labeling preparation, launch prep,...product risks are appropriately communicated. + Provide training to Regulatory Affairs and other departments as appropriate.… more
- J&J Family of Companies (Raritan, NJ)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... Innovative Medicine R&D is recruiting for a Senior Manager, Global Labeling Product Leader. This position is...develop methods for planning, directing, coordinating and controlling the regulatory affairs activities related to new and… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device...prioritization, objectives and setting clear expectations for the device regulatory strategy, including a global labeling… more
- Amgen (Washington, DC)
- …the world. In this vital role you will support products in the Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory ... do your best work alongside other innovative, driven professionals in this meaningful role. ** Regulatory Affairs Senior Director - Global Regulatory … more
- Boehringer Ingelheim (Ridgefield, CT)
- …US Product Group Regulatory Affairs will provide expert US regulatory leadership to the global and US cross-functional teams throughout the product ... policies. The Director, US Product Group Regulatory Affairs will proactively participate in US/ global cross-functional...Global RA Strategy, Risk Assessments). + Collaborates with US/ Global Labeling on early target label profile… more
- Amgen (Washington, DC)
- …transform the lives of patients while transforming your career. **Undergrad Intern - Global Regulatory Affairs Automation Associate** **What You Will Do** ... you will interact broadly across the functions/sub-functions within the Global Regulatory Affairs Execution Team... Regulatory Writing, Clinical Transparency & Disclosure, Global Labeling Strategy & Compliance, Global… more
- Kelly Services (Bridgewater, NJ)
- ** Regulatory Affairs Specialist Labeling ** Kelly(R) Science & Clinical is seeking a Regulatory Affairs Specialist - Labeling for our client based ... approvals + Knowledge of pharmaceutical, consumer or medical device industry regulatory affairs discipline throughout the product lifecycle including… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling , medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Jack Link's (Minneapolis, MN)
- …analytical, problem-solving and decision-making skills. + Expert knowledge and experience in food labeling and regulatory affairs , preferably with both USDA ... Meats(R), BiFi(R), Peperami(R) , Mariani and Local Legends Meat Snacks. The Sr. Regulatory Affairs Specialist is responsible for creating and assuring compliance… more
- Carrier (Beverly, MA)
- …to innovation, sustainability, and global impact. **About this role** As the ** Regulatory Affairs & Compliance Lead** at **Sensitech** , you will be the ... and data services. In this strategic individual contributor role, the ** Regulatory Affairs & Compliance Lead** collaborates cross-functionally with Product… more
- Boehringer Ingelheim (Ridgefield, CT)
- …or more therapeutic areas, interact effectively at all levels of the organization (local and global ), within Regulatory Affairs and across functions, as a US ... in one or more therapeutic areas. Interact effectively within Regulatory Affairs and across functions, as a... Regulatory Strategy Document. + In cooperation with US/ Global Labeling , provide project-related US regulatory… more
