- Takeda Pharmaceuticals (Columbus, OH)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director, Global Labeling Lead where you will be responsible ... teams to develop and update CCDS and other key global labeling documents (ie CCDS Working Team)...JPI, others as appropriate), consistent with the overall product strategy and information in the CCDS, when available. +… more
- AbbVie (North Chicago, IL)
- …LinkedIn. Job Description The Associate Director Regulatory Affairs, Strategic Global Labeling , combines the knowledge of scientific, regulatory, and ... European Summary of Product Characteristics (EU SPCs) and other Global Labeling . Under the direction of the...needs. + Presents process, strategy , and product labeling at Senior level meetings ( Global Regulatory… more
- Amgen (Washington, DC)
- …**Live** **What you will do** Let's do this. Let's change the world. As part of Global Labeling (GL), and under the supervision of the Therapeutic Area Lead, the ... marketing applications and variations. + Leads the cross-functional Labeling team as a Labeling Strategy...cross functional teams to ensure that the implementation of global regulatory labeling plans are aligned with… more
- Astellas Pharma (Northbrook, IL)
- …in remote work are encouraged to apply. **Purpose and Scope:** The Director CCDS Labeling Strategy Lead will report to the Executive Director, CCDS and ... Labeling , and sit on the labeling leadership...will independently interface and effect decisions with local and global team members (eg, Pharmacovigilance, Medical Affairs, and affiliates… more
- Ascendis Pharma (Princeton, NJ)
- …and the Americas and supporting global needs as required. The RA Associate Director, Labeling will be overall responsible for ensuring compliance with US ... The Regulatory Affairs (RA) Associate Director, Labeling will be responsible...Global Regulatory Lead for developing key messaging and strategy . Provide labeling advice and expertise… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …**EXAMPLE RESPONSIBILITIES:** + Leads or otherwise contributes to the development of the labeling strategy for multiple products and indications in the oncology ... Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs… more
- Kelly Services (Gaithersburg, MD)
- Description: The Labelling Strategy Associate Director provides regulatory labelling expertise, typically for more complex drug projects, to the Global ... Teams (PLT). This individual leads the development/implementation of the labelling strategy and maintenance of Core Product Information and United States (US)… more
- J&J Family of Companies (Raritan, NJ)
- …impact health for humanity. Learn more at https://www.jnj.com/. **Job Description** Janssen Global Commercial Strategy Organization, a group within Janssen ... resides in the Cardiovascular, Metabolic and Pulmonary Hypertension (CVM&PH) area of the Global Commercial Strategy Organization and reports to VP of Market… more
- Merck (North Wales, PA)
- …regulations, corporate standards and policies and business objectives. Actively participate in labeling and global regulatory team meetings to ensure support for ... anticipated promotional messages and claims (aligned with marketing strategy ) in clinical trial design and product labeling as it relates to the use of study… more
- Bristol Myers Squibb (Princeton, NJ)
- …reporting, contribution to benefit-risk assessment, risk management planning and strategy , and execution of certain post-marketing commitments and ensuring ... compliance with global regulatory requirements. **Position Summary** Leads Safety Data Review...programs, priorities, resources, and milestones. Drafts the early safety strategy plan, the Early Development Safety Roadmap (EDSR). Authors… more
- Sanofi Group (Bridgewater, NJ)
- …Strategist leverages their regulatory expertise to contribute to the definition of the global regulatory strategy , to enable and drive the execution of aligned ... US, EU and/or global regulatory strategy for assigned projects, including... (GRPS) and ensures alignment with the core product labeling for products in development as well as for… more
- Sanofi Group (Bridgewater, NJ)
- …Specialist leverages their regulatory expertise to contribute to the definition of the global regulatory strategy , to enable and drive the execution of aligned ... US, EU and/or global regulatory strategy for assigned projects, including... (GRPS) and ensures alignment with the core product labeling for products in development as well as for… more
- CSL Behring (King Of Prussia, PA)
- The Opportunity: The Clinical Trial Supply (CTS) Asset/Program Lead ( Associate Director) is an experienced clinical supply chain professional accountable for the ... development and execution of the clinical supply operational strategy for an asset or program (a group of...Development Teams, as well as with Commercial, Operations and Global Supply Planning. 2. Influences protocol design and leverages… more
- Lilly (Indianapolis, IN)
- …for regulatory purposes meets all necessary regulatory standards. + Responsible for global registrations, labeling and label modifications, and resolution of ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- …responses, and new submissions, and RA leadership team representative. + Responsible for the global regulatory strategy for UCC products + Leads the RA function ... **Job Description Summary** As Associate Director, Regulatory Affairs, you will be responsible...for managing a team that develops and executes the strategy and timelines for submission of various regulatory licensing… more
- J&J Family of Companies (Columbus, OH)
- Associate Director, Regulatory Affairs - 2406166277W **Description** Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is ... recruiting for an Associate Director, Regulatory Affairs. This position can be located...exist. + Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent and unified… more
- Boehringer Ingelheim (St. Joseph, MO)
- …and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering ... programs reflect Boehringer Ingelheim's high regard for our employees. As the Manager/ Associate Director, Regulatory Affairs Pharma Safety & Efficacy you will: Act… more
- RTX Corporation (Fairfield, CA)
- …a highly motivated and flexible individual to fill the role of a Materials Associate I, Packaging. You will be responsible for the safe and proper packaging of ... computer skills + Attention to detail, strong sense of organization. + BarTender labeling software experience or equivalent labeling software + Experience in SAP… more
- PCI Pharma Services (Rockford, IL)
- …in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape ... Life changing therapies. Global impact. Bridge to thousands of biopharma companies...Project Team meetings. + Creates project specific documentation including packaging/ labeling protocols, variable data forms, sample shipment request forms,… more
- RTX Corporation (Oklahoma City, OK)
- …400, Oklahoma City, OK, 73135 USA Position Role Type: Onsite The F135 Warehouse Associate aids with managing inventory and movement of materials. The Associate ... or shipper questions and complaints regarding storage and distribution services. The Associate performs a variety of tasks supporting the Collins F135 Aftermarket… more