- Cardinal Health (Sacramento, CA)
- …joins a team of medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs. **Responsibilities:** + Collaborate across multiple ... hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas,… more
- Abbott (Sylmar, CA)
- …strategies for new FDA 510(k) AI-based SaMD modules. Support international regulatory submissions. + Ensure AI solutions comply with relevant regulatory ... scientific findings, and cultivate partnerships with academia, startups, and regulatory bodies. **Qualifications** + Bachelor's degree required. Ph.D. required in… more
- AbbVie (South San Francisco, CA)
- …key Clinical Pharmacology information/strategy to senior and executive management, regulatory agencies, and external peers. Supports strategic planning for drug ... cost, quality/performance). + Provides scientific and strategic consultation to R&D, Regulatory , and all levels of management on critical decisions and development… more
- Bristol Myers Squibb (San Diego, CA)
- …trials and will supervise and have accountability for the clinical components of regulatory filings + Will contribute to overall strategy for specific disease / ... and Communication + Will work closely with colleagues in BMS Research, Development, Regulatory , Medical, Commercial and other key functional areas on a global basis;… more
- Abbott (Pleasanton, CA)
- …Institute efficient communication and cross-functional collaborations with marketing, quality, regulatory , clinical, project management, etc, at multiple levels. + ... Interfaces with appropriate internal and external stakeholders ( regulatory , customers, etc.) to ensure development programs meet regulatory and customer… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …The role is essential in ensuring that all quality-related activities meet regulatory standards and uphold Takeda's commitment to excellence. The incumbent will work ... Quality Systems procedures across departments, driving consistent compliance + Ensure regulatory conformance across multiple operational areas + Identify and resolve… more
- Pfizer (South San Francisco, CA)
- …investigator brochures, clinical study reports, statistical analysis plan, and regulatory documents. + Provide leadership to early stage clinical scientists ... with other clinicians, statisticians, clinical pharmacologists, translational biologists and regulatory specialists. Meet regularly with the Pfizer Oncology group… more
- Gilead Sciences, Inc. (La Verne, CA)
- …+ Works directly with international affiliates and distributors to ensure that regulatory inspections are managed in accordance with Gilead corporate guidelines and ... responses are submitted in accordance with regulatory requirements. + Conducts and serves as a lead/coordinator of investigations and corrective and preventative… more
- Abbott (Pleasanton, CA)
- …closely with cross-functional peers in quality, operation, marketing, clinical and regulatory , medical affairs, commercials to define an aligned and predictable NPD ... protected. + Interfaces with appropriate internal and external resources ( regulatory , customers, etc.) to ensure development programs meet regulatory… more
- AbbVie (Irvine, CA)
- …strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues. ... of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses and other program documents. *May oversee… more