- University of Washington (Seattle, WA)
- …natural beauty. **UW Medicine has an outstanding opportunity for a Director of Clinical Regulatory Affairs and Associate General Counsel to join their ... team.** **GENERAL DESCRIPTION AND PURPOSE** The Director of Clinical Regulatory Affairs (Director), Associate General Counsel for UW Medicine Nonprofit… more
- Gilead Sciences, Inc. (Boston, MA)
- …impact. Join Gilead and help create possible, together. **Job Description** Job Description Regulatory Affairs Labeling is a core function within Gilead's Global ... Regulatory Affairs organization and acts as a...in the various stages of drug development from early research through post-marketing. + Demonstrates advanced regulatory … more
- Abbott (St. Paul, MN)
- …catheters and software, vessel closure devices and peripheral stents. **The Opportunity** This ** Associate Director Regulatory Affairs ** will work on-site at ... Vascular Division. As a manager, the function of an Associate Director Regulatory Affairs is... regulatory preferred but may consider quality assurance, research and development/support, scientific affairs , operations, or… more
- Actalent (Des Moines, IA)
- …trials. * Review, update and draft new Standard Operating Procedures (SOPs) within the Regulatory Affairs Department as needed. * Review and prepare outlines of ... Quality Assurance efforts. * Perform other assigned duties as required. Skills: Regulatory affairs , Regulatory , Pharmaceutical, Document Control, … more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director Regulatory Affairs , Strategic Global Labeling, combines ... the knowledge of scientific, regulatory , and business issues to enable products that are...Research & Development (R&D) and commercial to meet regulatory labeling needs. Provides labeling input for Risk Management… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Associate Director, External Research , Scientific Affairs provides strong subject matter expertise, operational oversight and process ... cross-functional experiences with marketing, commercial, finance, development and/ or medical affairs ) or applicable clinical/academic experience in a research … more
- Amneal Pharmaceuticals (Piscataway, NJ)
- … Associate II assists with minimal guidance, the Director of Specialty Regulatory Affairs with all IND/NDA related activities. Essential Functions: + ... intelligence + Manage clinicaltrials.gov database Additional Responsibilities: + Backup eCTD publishing + Special regulatory research projects as needed more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …Annual Reports and other duties as needed. **Primary responsibilities for the Regulatory Affairs Specialist role:** + Manages dossier compilation for product ... translations, legalizations and apostilled documents with vendors for all North America regulatory affairs . + Coordinates all Annual Reports of Minor Changes… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
- Teleflex (Wyomissing, PA)
- Regulatory Affairs Specialist **Date:** Apr 19, 2024 **Location:** Wyomissing, PA, US **Company:** Teleflex **Expected Travel** : None **Requisition ID** :9538 ... make a difference in patients' lives. **Position Summary** This is a mid-level regulatory affairs position that requires the ability to integrate regulatory… more
- Merck (North Wales, PA)
- …Director/Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is responsible for the review and approval of all US ... promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent… more
- Novo Nordisk (Lexington, MA)
- …documents to regulatory agencies. Relationships Report to a Director of Regulatory Affairs . Develop and maintain positive rapport and working relationships ... with other personnel in Regulatory Affairs and other local and headquarter...applications + Contribute to the generation and review of regulatory strategy documents + Research and analyze… more
- Fresenius Medical Center (Waltham, MA)
- …teams by interpreting and strategically applying regulations, guidances and available research /information. + Plans, prepares and submits varied regulatory ... can be fully remote. **PURPOSE AND SCOPE:** Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product… more
- Novo Nordisk (Plainsboro, NJ)
- …designated personnel. Relationships Report to the Director/ Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and ... maintain positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and headquarter departments to accomplish… more
- Amgen (Washington, DC)
- …your best work alongside other innovative, driven professionals in this meaningful role. ** Regulatory Affairs Manager - Regional Regulatory Lead** **Live** ... and technical Regulatory guidance relating to Amgen products. + Perform regulatory research to acquire relevant histories, precedence and other information… more
- AbbVie (Mettawa, IL)
- …materials in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs. Qualifications Associate ... discovery, statistics, regulatory , etc.) as they relate to on-going medical affairs projects. + May assist as consultant and liaison with other corporations when… more
- AbbVie (North Chicago, IL)
- …across the organization, including Commercial Leadership, Medical Affairs , Regulatory Affairs , Corporate Communications, Research and Development ... @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director, Business Unit Communications and Public Affairs -… more
- City of New York (New York, NY)
- Job Description Reporting to the Director of Intergovernmental Affairs , the Government Affairs Associate will provide support to the Office of ... in the areas involving policy, legislative, external and community affairs work. The Government Affairs Associate...but are not limited to the following: - Monitor, research and analyze proposed legislative and regulatory … more
- Veterans Affairs, Veterans Health Administration (Boston, MA)
- …to traumatic stress and PTSD. 4. Prepares and ensures compliance with all research regulatory requirements. 5. Prepares and submits initial, ongoing, and final ... contribute to both generation and dissemination of knowledge in support of the research and educational missions of the National Center for PTSD. The overall… more
- ElectriCities of North Carolina (Raleigh, NC)
- Overview The mission of the Legislative Affairs Associate is to enhance and promote public power in North Carolina by providing strategic government affairs ... positive public image among residents, municipal, and legislative officials. The Legislative Affairs Associate is responsible for increasing the awareness of and… more