- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …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. (Austin, TX)
- …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
- Lilly (Houston, TX)
- …and OUS: Includes networking with Supply chain, Global Quality Leaders, Senior Management , Legal, Regulatory , Global Patient Safety, Qualified Persons at ... to those who need them, improve the understanding and management of disease, and give back to our communities...is responsible for providing GMP/GxP support across the different regulatory reporting and inspection support that is provided by… 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...platform. + Lead internal process to obtain, coordinate, and document cross-functional SME impact assessments of new or updated… more
- Sumitomo Pharma (Austin, TX)
- …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
- The City of Houston (Houston, TX)
- Environmental Investigator II/ Regulatory Compliance Print (https://www.governmentjobs.com/careers/houston/jobs/newprint/5160349) Apply Environmental Investigator ... II/ Regulatory Compliance Salary $2,085.89 - $2,259.00 Biweekly Location Houston,...with EPA, TCEQ, and City of Houston standards. + Document field activities with accurate records, chain of custody… more
- Capital One (Plano, TX)
- …GEA organization comprises Community Reinvestment Act (CRA) Strategy & Program Management , Global Policy Affairs Group, Regulatory Relations, Corporate ... Automation (DATA) team which is responsible for the data management , analysis and regulatory reporting of the...tools + Manage team's annual job aid and procedure document update exercises + Assist with preparations related to… more
- Prime Therapeutics (Austin, TX)
- …ensure fee schedule revisions align with Supply Chains COGS strategies for specialty drug management + Lead and implement network initiatives by facilitating and ... from negotiation of all terms, ensuring Prime and Pharmacy compliance and document retention aligning with Prime's Record Information Management (RIM) policies… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …of drug development principles and clinical trial implementation and management . + Complete understanding of the global regulatory requirements. + ... a major impact on human health. OPDC develops promising drug candidates, starting with clinical trial management ,...with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible… more
- Hargrove Engineers & Constructors (Conroe, TX)
- …Are** Hargrove supplies unparalleled services in engineering, procurement, construction management , and technical services in the industrial, commercial, and ... **Job Scope:** The E & I Engineer (Process Safety Management ) is generally responsible for performing all aspects for...(MOC) and Pre-Startup Safety Reviews (PSSR). Coordinate, conduct and document ad hoc PHAs as required for MOC and/or… more