- Gilead Sciences, Inc. (Foster City, CA)
- …designated regional regulatory activities for PDM CMC Project and Commercial Teams, Regulatory Project and Regulatory Submissions Teams, with focus on ... Under the guidance of more senior staff, oversees the preparation of CMC regulatory submissions for investigational and commercial products with solid scientific… more
- Meta (Burlingame, CA)
- …at reviewer level. All significant issues will be reviewed with the manager 2. Support regulatory compliance activities, including site registration, audits, ... etc., as needed 3. Prepare FDA, European and Canada submissions for product changes as required to ensure timely...to ensure timely approval for market release. Review significant regulatory issues with manager , as necessary, and… more
- Medtronic (Santa Rosa, CA)
- …influences the preparation of documentation to support innovative and high-quality regulatory submissions from early phase strategies, marketing applications, ... Strategic direction is expected to support a number of regulatory applications which may include, FDA Pre- submissions ,...computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA interactions to meet the aggressive ... **_General Description:_** BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …content for promotional and educational materials, clinical trial protocols, and regulatory submissions . + Establish and maintain appropriate scientific ... Kite, a Gilead company is hiring a **Senior Medical Manager ** to support US Medical Affairs. As a Senior...and internal policies for medical affairs activities. + Support regulatory submissions , including safety reporting, clinical trial… more
- Insight Global (San Diego, CA)
- …team members to maximize chances for first pass approval of IVD regulatory submissions , compliant with the appropriate regional or national regulations. ... supervision. Develops, implements and documents policies and procedures within the regulatory affairs department under supervision of manager . Participates in… more
- Sumitomo Pharma (Sacramento, CA)
- …medical writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and ... Safety (ISS) and Integrated Summary of Efficacy (ISE) strategy for NDA/BLA submissions , ensuring compliance with regulatory expectations. + Collaborate closely… more
- Deloitte (San Jose, CA)
- …Q8, Q9, Q10), FDA/EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years experience leading, ... equitable future of health. Work You'll Do As a Manager you will lead and deliver engagements, or components...like GenAI, AI/ML, and automation for analytical methods, manufacturing, regulatory and/or QA/QC + Implementation of regulatory … more
- Umpqua Bank (Roseville, CA)
- Client Solutions Manager Commercial Banking Roseville, California **Description** **About Us:** At Umpqua, we create a great place to work by offering a unique brand ... grow new and existing commercial business relationships. The Client Solutions Manager (CSM) is a second, primarytouch-pointbetween Bank and Client. Responsible for… more
- Abbott (Alameda, CA)
- …in more than 160 countries. **The Opportunity** : The Associate Clinical Project Manager is responsible for managing and meeting the objectives of clinical projects. ... Internally interfaces with data management, biostatistics, regulatory , clinical research associates, Finance, field clinical specialists, and cross-functional team.… more