- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …systems needed for the function including and not limited to CREDO (document management ), PRISM ( regulatory information management system), Global Trackwise, ... investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead. + … 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
- GRAIL (Austin, TX)
- …provide direction to regulatory staff and, when required, participate in senior management meetings as a delegate. The role fosters a work culture aligned with ... when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders...**Experience** + Minimum of 10 years of experience in regulatory , development, clinical affairs, quality, or program management… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …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...and supporting senior leadership. + Previous experience with people management and team leadership. + Excellent interpersonal and communication… more
- American Electric Power (Austin, TX)
- …and provides facilitation of the implementation in the needed areas of change . With extensive level regulatory knowledge, educates others on interrelationships ... and strategies in a clear, concise and effective manner to management and/or regulatory bodies; demonstrates a developed knowledge of the network channels within… more
- Oracle (Austin, TX)
- …an unprecedented rate, the success of large, complex global health companies requires regulatory leaders who are deeply steeped in the public and private levers that ... To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing laws,… more
- ThermoFisher Scientific (Austin, TX)
- …product change requests including impact assessment. + Propose innovative regulatory options for new products or claims. + Manage departmental budget. + ... interaction with cross-functional teams, such as Research and Development, Product Management , Marketing, Quality Assurance, Manufacturing and with Regulatory … more
- ExxonMobil (Spring, TX)
- …Evaluate, advise, and make recommendations with prioritization and potential outcomes to Management for policy, legislative and regulatory actions that may ... will play in our team** Join ExxonMobil as a Regulatory Affairs Advisor supporting the Permian Business Unit. Become...cross-functional teams to solve issues. Lead or advise Issue Management Team with a process to manage and steward… more
- Bausch + Lomb (Austin, TX)
- …ANDAs and amendments/supplements. + Serve as RA representative on facility/site Local Change Management Boards. + Ensure operational excellence, compliance, and ... external regulatory stakeholders and shape the external regulatory environment + Advanced Project Management /...the external regulatory environment + Advanced Project Management / leadership experience with the ability to influence… more