- Sumitomo Pharma (Sacramento, CA)
- … regulatory affairs activities; provide relevant input to Leadership + Oversee the regulatory activities at CROs, providing document review in order to ensure ... in compliance with FDA regulations and Company policies + Serve as the regulatory member of the scientific Medical Review Committee (sMRC) to ensure… more
- Sumitomo Pharma (Sacramento, CA)
- …expert on all regulatory matters with key external stakeholders, internal steering/ review committees, business partners, and government entities on a global ... regulatory strategies are aligned to the SMP group business strategy + Collaborate with Head of RA at...Responsible for providing global guidance and monitoring of global regulatory line items in the clinical development… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Diploma/GED and 14+ years of relevant industry experience Preferred Qualifications: + Regulatory review of promotional materials for prescription drug and/or ... for providing commercial regulatory strategy and direction to enable the US business to meet its commercial needs in support of patients and in a compliant… more
- Medtronic (Santa Rosa, CA)
- …training and support to other junior members of the department. + Provide regulatory review and guidance for proposed product claims/labeling and advertising and ... their product changes as required to ensure timely approval for market release. Review significant regulatory issues with manager, as necessary, and resolve… more
- BeOne Medicines (San Mateo, CA)
- …for development programs to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal ... regulatory strategy. Externally, the individual will interface with business partners regarding global development, regulatory , and registration strategies.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Responsible for ensuring preparation of the Product Company Core Data Sheets (CCDS), regulatory review of draft Product Company Core Safety Information (CCSI) ... all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and… more
- Medtronic (Irvine, CA)
- …may include the following and other duties may be assigned. + Support review of advertising and promotional material to ensure that it meets all medical, ... legal, and regulatory (MLR) process... (MLR) process requirements. + Facilitate online and offline review meetings with authors, reviewers/approvers to ensure content approval… more
- BeOne Medicines (Emeryville, CA)
- …to support clinical trials where necessary, and facilitate marketing authorization in line with business objectives, and in coordination with key internal ... **General** **Description:** The Director, Regulatory Affairs, Dx/CDx and Medical Devices will be...and approvals, with a quality focus to minimize cyclical review + Lead and mentor team members + Maintain… more
- Banc of California (Santa Ana, CA)
- …collaborative team approach within Credit Review as well as with other line of business units, maintains effective working relationships with lending unit ... methodologies and implement other critical elements for a credit review program to align with heightened regulatory ...which do not accurately identify correct risk ratings in line with bank policy and regulatory guidance… more
- Stantec (Walnut Creek, CA)
- …for distressed business units and BCs. Including focus on write-offs and business line expenses. - Supports achieving utilization rate and backlog targets ... for the top line , the BCPL leads the growth of the Business Center (BC) and Stantec's market position while providing innovative design solutions with… more