- Wells Fargo (New York, NY)
- …delivery. **In this role, you will:** + Lead the delivery of Document Intelligence AI projects using Agile methodologies, ensuring alignment with business goals ... solutions and promoting data excellence. + Make decisions in end-to-end project management , demonstrating ownership of the entire process from beginning to end +… more
- Parexel (Albany, NY)
- …+ Solid aptitude for use of IT systems; Regulatory Information Management System (RIMS), electronic document management system (EDMS), Proficiency ... the development of appropriate responses. * Participate in Safety Management Team (SMT) and Global Regulatory Team...manage the review and approval of labeling in a document management system. + Electronic document… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). **Competencies** See OPDC Competencies ... strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …tools and systems needed for the function including and not limited to CREDO ( document management ), PRISM ( regulatory information management system), ... investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead. + … more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …typical day might include the following:** + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to ... The Senior Manager, Regulatory Affairs will report to the Global ...novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …annual budget, and manage spend. + Author and conduct periodic review of regulatory intelligence management Standard Operating Procedures or work practices. + ... The Associate Director of Regulatory Intelligence leads the collection and dissemination of...platform. + Lead internal process to obtain, coordinate, and document cross-functional SME impact assessments of new or updated… more
- Bank of America (New York, NY)
- …ensuring the Global team is adherent to multiple Enterprise policies eg, Regulatory Reporting and Enterprise Data Management Standards * Effective running ... Strategy experience will be a plus * Experience with regulatory programs * Experience with global stakeholder management...the dangers and resulting consequences of illegal and illicit drug use and alcohol abuse. Our Drug -Free… more
- Sumitomo Pharma (Albany, NY)
- …will be responsible for leading development of all non-clinical and clinical regulatory strategies including management of IND and NDA submissions, FDA ... activities; provide relevant input to Leadership + Oversee the regulatory activities at CROs, providing document review...experience in preparing strategies for and submitting applications for drug or biologic products (INDs, NDAs, MAAs) + NDA… more
- Intertek (Cortland, NY)
- Engineer - HVAC Safety, Regulatory Compliance Intertek, a leading provider of quality and safety solutions to many of the top recognized brands and companies is ... actively looking for an Engineer - HVAC Safety, Regulatory Compliance to join our Electrical team in Cortland,...applicability. + Set up and operate EUT; perform and document simple repairs on EUT as needed. + Perform… more
- Merck (Albany, NY)
- …Associate Principal Scientist, Regulatory Authoring Business Owner, will optimize regulatory authoring processes and enhance data management by working with ... Experience and Skills** + Experience implementing or supporting automated regulatory authoring (structured content, template-driven generation, or document … more