- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Position Summary** : Reporting to the Vice President, Global Medical Affairs, the Executive Director , CNS Strategy, Global Medical Affairs is a leadership ... for the strategic and tactical medical plans of both global and US medical CNS products. This individual is...Otsuka prominence in CNS space + Provides input into regulatory documents, including product labeling + Accountable… more
- BeOne Medicines (Emeryville, CA)
- The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs (often ... multi-indication) and creates and maintains a single interpretation of global safety data for developmental and marketed products. With the support of Safety… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- … submission content (510(k), Technical Files, etc.) + Develop and implement global regulatory strategy for MMS Dispensing Medical Device and non-Medical ... self. Become a maker of _possible_ with us. The Director of Regulatory Affairs reports directly to...PowerPoint, Teams + Project Management experience + Knowledge of global Regulatory Affairs requirements, regulations and standards… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …auditors, providing mentorship, performance evaluations, and long-term career development. The Director ensures compliance with global regulatory ... Director for a GxP Auditing role. The Director of GxP Auditing will lead Kite's global...Define and execute a comprehensive audit strategy aligned with global regulatory expectations (FDA, EMA, MHRA, PMDA,… more
- BeOne Medicines (Emeryville, CA)
- …+ Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update ... experience, including individual study design and filing plans. + Experienced in global regulatory requirements for pharmacovigilance. **Travel:** Less than 10%… more
- BeOne Medicines (San Mateo, CA)
- …Lead the analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update ... is preferred. + Pharmaceutical product development experience + Experienced in global regulatory requirements for pharmacovigilance **Travel:** Less than 10%… more
- Edwards Lifesciences (Irvine, CA)
- Imagine how your ideas and expertise can change a patient's life. Our Global Supply Chain team plays a central part in ensuring our products are delivered to ... the medical device industry. Whether your work includes strategic inventory planning, labeling , warehouse management, material handling, or any of our other supply… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- … agencies, including end-to-end process improvements, procedural updates, design/manufacturing/ labeling changes, etc. + Coordinates and facilitates a unified ... makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the...creation and management of communications with FDA and other regulatory agencies, 2) ensuring that commitments made to the… more
- Ascendis Pharma (Palo Alto, CA)
- …knowledge of FDA, EMA PV regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations. + ... Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe,...laws and regulations and as appropriate, local and foreign regulatory reporting requirements and for signal detection, evaluation and… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- **Job Description Summary** Sr Design Quality Systems Manager reports to the Director , Quality Management, WWIPD. The Sr Design Quality Systems Manager is ... makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the...manage external audits. + Provide Quality functional support for labeling programs and labeling process improvement activities.… more