- Gilead Sciences, Inc. (Foster City, CA)
- …will join an active therapeutic area with phase 3 and 4 PBC studies and global regulatory filings underway or expected, with potential for work across earlier ... /products considering both strategic and technical aspects + Contribute to global regulatory filing strategy and lead clinical development contributions in the… more
- Medtronic (Los Angeles, CA)
- …risk tolerance. + Ensure compliance with all internal controls, treasury policies, and global regulatory requirements. + Build and lead a high-performing ... focuses on improving the lives of those within the global diabetes community. As a business, we strive to...with a clear understanding of public company readiness and regulatory requirements. **Why Join Us?** + Shape the treasury… more
- J&J Family of Companies (San Diego, CA)
- …Clinical Development and Clinical Pharmacology experience is preferred. + Knowledge of global regulatory requirements, ICH, GCP and clinical trial terminology is ... and other relevant stakeholders at the CDT. The TM SRP collaborates with Global Development Operations (GDO) and the entire Trial Team to operationalize studies… more
- Amgen (Thousand Oaks, CA)
- …area to a range of audiences, including executive leadership, development partners, and global regulatory agencies. This role will include global development ... product strategy. The Executive Director will report into the Vice President, Global Clinical Development. **Responsibilities** + Serve as the global development… more
- Bristol Myers Squibb (Brisbane, CA)
- …industry standards + Extensive experience in preparing and participating in global regulatory agency interactions + Demonstrate excellent collaboration, ... plans to support product development or market access objectives in a global organization. The Senior Director provides expertise and guidance in collaboration with… more
- Stryker (San Jose, CA)
- …CA / Flower Mound, TX Stryker is hiring a Senior Project Manager, International Regulatory Affairs to expand global access to our Endoscopy division product ... You will collaborate closely with business unit and cross functional leadership, regulatory teams, and global partners to drive alignment, ensure compliance,… more
- Cordis (Irvine, CA)
- …Team Leader, ability to inspire and support a team. + Proven track record in global regulatory body interactions + Strong communication skills. + Global , ... at every stage of the manufacturing process, ensuring compliance with regulatory standards and internal quality requirements. + Process Improvement: Lead the… more
- Hologic (San Diego, CA)
- … regulatory reports (eg, FDA MDR, EU Vigilance, FSCA/FSN) according to global regulatory requirements. + Ensure post-market activities are compliant with ... unique opportunities to enable our Purpose, Passion, and Promise to empower global health advancements. Our Quality Assurance department is looking for a dedicated… more
- Merck (San Francisco, CA)
- …pharmacometric analyses + Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring ... Population Pharmacokinetics, R-Studio, Teamwork **Preferred Skills:** Drug Discovery Process, Global Regulatory , Machine Learning, Multidisciplinary Collaboration, Multiple… more
- Amgen (Thousand Oaks, CA)
- …quality systems. + Ensure site's process validation business process adheres to global regulatory agency standards, Amgen's quality requirements, other site ... process technology transfer and other technical documents. **Process Validation & Regulatory Support** + Development of validation plans and supports execution of… more