- Takeda Pharmaceuticals (Boston, MA)
- …and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , ... the Company-wide patient safety expert for assigned pharmaceutical / biological / drug- device combined products, accountable for the safety strategy and major safety… more
- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... regulatory activities/submissions and 3 years working on developmental products. Previous regulatory affairs experience is preferred. + Experience in working… more
- ITG Brands (NC)
- …US jurisdiction. + Minimum of 10 years of legal experience, in a highly regulatory industry (tobacco, pharmaceuticals, medical devices ). + Strong background ... responses, including strategy, redactions, and risk mitigation. Partner with Quality and Regulatory Affairs teams to support consumer complaint intake, quality… more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory… more
- Amgen (Washington, DC)
- …will lead the end-to-end digital strategy, delivery, and operational excellence of Global Regulatory Affairs and Safety (GRAAS) systems. This role will provide ... & Program Ownership** + Lead the global digital strategy and roadmap for regulatory operations across domains such as RIM, CMC/ device , labeling, publishing,… more
- Abbott (Sylmar, CA)
- …integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. Medical device industry ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Houston Methodist (Houston, TX)
- …and the International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of ... research environment or FDA regulated industry + Experience in medical devices , diagnostics, or pharmaceuticals and/or within...N/A **LICENSES AND CERTIFICATIONS - PREFERRED** + RAC - Regulatory Affairs Certifications (RAPS) **OR** + CCRC… more
- Abbott (Plymouth, MN)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... ethical standards. + Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) Preferred Qualificaitons: + BA or BS degree in… more
- Edwards Lifesciences (Irvine, CA)
- …clinical investigations, etc.). . Monitoring legal developments applicable to the Healthcare Regulatory and medical device spaces. . Other duties ... and other Business Unit or Corporate functions such as Regulatory Affairs , Compliance, and others. . Reviewing...negotiating clinical trial agreements and associated contracts in the medical device or pharmaceutical industry or at… more
- Integra LifeSciences (Braintree, MA)
- …communicating testing activities. The role works with Product Development, Project Management, Regulatory , Marketing and Medical Affairs . **ESSENTIAL DUTIES ... in close collaboration with Product Development, Project Management, RA, Marketing and Medical Affairs . Support Design Reviews, Technical Reviews, and Gate… more