- Pfizer (San Diego, CA)
- …and solid understanding of related disciplines, eg, Clinical Operations, Data Management , Safety, Biostatistics, Regulatory , Study Management , Pre-Clinical, ... study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. Foster a transparent environment that builds strong partnerships… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …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
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …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
- Ascendis Pharma (Palo Alto, CA)
- …The Regulatory Project Manager will be an integral part of Global Regulatory Affairs, providing project management leadership to key global regulatory ... ensure the delivery of business objectives. + Participate in Regulatory filing teams, providing project management expertise...minimum of 8 years of experience: 5 years in drug , biologic and/or combination products in Regulatory … more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …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 (Sacramento, CA)
- …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
- BeOne Medicines (San Mateo, CA)
- …execution** **Optimize current state clinical operations processes and maintain document lifecycle management and continuous process improvements** **Develop ... and collaboration with cross functional leaders/stakeholders (eg Clinical Development, Data Management , Quality, Regulatory ) as it relates to planning,… more
- Bank of America (San Francisco, CA)
- Credit Advisor, Global Wealth & Investment Management Denver, Colorado;San Francisco, California **To proceed with your application, you must be at least 18 years of ... be at least 18 years of age.** Acknowledge (https://ghr.wd1.myworkdayjobs.com/Lateral-US/job/Denver/Credit-Advisor--Global-Wealth Investment- Management \_25037156) **Job Description:** At Bank of America, we are… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …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
- BeOne Medicines (Emeryville, CA)
- … system + Advanced application capability with Excel, PowerPoint, Word, and electronic document management system (ie, Veeva) + Advanced knowledge of data mining ... signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory -required periodic reporting. Physicians in this… more
