- Sanofi Group (Morristown, NJ)
- …approve design control deliverables. + Contribute to product development and lifecycle management planning. + Provide regulatory impact assessments for proposed ... including generating submission content plans, submission tracking, communication and document management + Contribute to internal regulatory processes and… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- … compliance with the ability to propose solutions or escalate to upper management . + Review, monitor and coordinate regulatory meetings to review surveillance ... that has direct impact to the business. + Ensure management is aware on the status of submissions/applications. +...is aware on the status of submissions/applications. + Provide regulatory assessment on change controls for proposed… more
- Globus Medical, Inc. (Audubon, PA)
- …and achieves timely regulatory clearance/approval for marketing. + Develops Regulatory team expertise in project management , writing, testing methods, and ... class II and class III products. This position entails management of submissions to the FDA, requiring working knowledge...submission content as needed. + Reviews and approves Document Change Orders for US Regulatory , including … more
- Takeda Pharmaceuticals (Boston, MA)
- …with data quality and governance tools (eg, Informatica, Collibra, or equivalent). + Change management or process improvement certification (eg, Lean, Six Sigma, ... and compliance of regulatory data within the Company's Regulatory Information Management (RIM) ecosystem. This role combines hands-on data analysis and… more
- Lundbeck (Deerfield, IL)
- …support. + Liaises with CFTs to support labeling related Information requests from Regulatory bodies regarding label content and labeling change requests. + ... labeling and systems problems. + Ability to influence division management at all levels to support regulatory ...division management at all levels to support regulatory compliance needs. + Highly proficient in communicating strategic… more
- LSI Solutions (Victor, NY)
- …competent authorities, and/or authorized representative. + Complete all assigned quality management system training on schedule. + Perform regulatory ... assigned. Level II + All essential functions listed above. + Locate all regulatory certificates. + Independently generate document change requests as needed. +… more
- Sacramento Municipal Utility District (Pollock Pines, CA)
- …Microsoft SharePoint and SAP platforms to develop, manage, and optimize information management systems for regulatory compliance and information sharing + Proven ... Title: Regulatory Coordinator Generation Department: PG Administration Location: Pollock Pines, CA, US, 95726-1500 Category: **Minimum Pay Rate:** $123,531.20… more
- Delek US Holdings (Dallas, TX)
- …Compliance, & Risk Management + FLSA Status: Exempt + Job Function: Regulatory Affairs and Compliance + Job Level: Professional III **JOB SUMMARY** Maintains the ... + Relationship Management + Acts as a knowledgeable resource for Regulatory Compliance, specifically DOT 195, TRRC (comprehensive, safety, OQ, CRM, D&A, state of… more
- Takeda Pharmaceuticals (Boston, MA)
- … requirements, including eCTD4, SPOR/IDMP, and CTIS/EU CTR. + Oversee master data management for regulatory data and partner/ drive connectivity with RD and ... leadership, and other stakeholders for pipeline realization and post-approval lifecycle management . + Provide standard regulatory reports and dashboards and… more
- Charles Schwab (Lone Tree, CO)
- …this role to work on site in the specified locations.** The Financial and Regulatory Reporting Team function within Schwab Asset Management (SAM) is responsible ... management + Communicating and presenting to senior management in SAM on financial and regulatory ...skillset to identify areas of opportunity and implement effective change and automation + Proactively support business partners and… more