- J&J Family of Companies (Titusville, NJ)
- …interactions also includes individuals from project management, TA strategy, global regulatory affairs , finance, legal, quality assurance, quality monitoring & ... of medical publications emerging from the Team and its affiliates + Assists Regulatory Affairs in the development of drug/device regulatory strategies… more
- J&J Family of Companies (Titusville, NJ)
- …for product hierarchies, nomenclature, and lifecycle transitions. + Partner with Regulatory Affairs , Clinical Operations, Supply Chain, and Commercial to ... IM), a pharmaceutical company of Johnson & Johnson is recruiting for a ** Director ,** **R&D Data Science,** **MDM Products** This position has a primary location of… more
- Bristol Myers Squibb (Brisbane, CA)
- …(Masters, PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry. **Key Competency Requirements** ... in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director , Global Regulatory Strategy, Neuroscience** **Position Summary:** The… more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for...to the authoring of modules 2.7.3, 2.7.4, 2.5 and labeling for regulatory submissions, contribute the authoring… more
- Edwards Lifesciences (NY)
- …Conduct technical, product briefings for cross functional teams such as complaints, Engineering, regulatory affairs , quality affairs and clinical affairs ... **Sr. Director , Global Professional Education, Training - IHFM** Many...to meet deliverable timelines + Expert understanding of product labeling content approval processes and systems, regulatory … more
- AbbVie (Mettawa, IL)
- …inform COA measurement strategy for clinical trials and interfaces with external global regulatory [e.g. FDA, EMA etc.] to support labeling negotiations. + ... cross-functional audiences. Key Stakeholders Other evidence generating functions (R&D, epidemiology, medical affairs ), as well as regulatory , US, Area & Global… more
- JBS USA (Greeley, CO)
- … regulatory , and food safety practices. In this role, you will manage and advise regulatory staff with any labeling or regulatory issues. You will also ... **Description** Director of Food Safety and Quality Assurance Purpose...co-packers. Additionally, you'll direct Customer Service/Sales and advise Consumer Affairs on complaints or technical questions. Responsibilities: + Lead,… more
- Candela Corporation (Marlborough, MA)
- …improvement actions related feedback. . Jointly accountable with Quality System (QS) and Regulatory Affairs (RA) Leadership for ensuring the QS is effectively ... **Sr. Director , Design and Supplier Quality** Requisition Number **2882**...Computer System/Software (non-product) Validation (CSV), Periodic/Ad-hoc risk reviews, Sterilization, Labeling , and Design Transfer. You also play a significant… more
- Takeda Pharmaceuticals (Boston, MA)
- …with functional experts across the R&D organization, such QS, Research, Biostatistics, Regulatory Affairs , DMPK, Pharm Sci, and Clinical Science providing ... that will inspire you and empower you to shine? Join us as Senior Director , Quantitative Clinical Pharmacology Lead in our Cambridge, MA office. At Takeda, we are… more
- AbbVie (North Chicago, IL)
- …collaboration with cross-functional teams and counterparts in quality systems, regulatory affairs , medical writing, clinical development, clinical operations, ... contribution to post market surveillance activities, input to compliant regulatory authority reporting, development and implementation of lifecycle safety risk… more