- Gilead Sciences, Inc. (Foster City, CA)
- …degree is preferred. + A proven track record of developing and leading global CMC regulatory submissions strategies and submissions in all phases of drug ... CMC RA staff. + Contributes to update, maintain, and verify documents, submissions and registrational details in a validated Regulatory Information Management… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …FDA's guidance on device versus non-device functionality. + Prepare, submit, and manage regulatory submissions for SaMD products. + Evaluate the impact of ... **Job Description Summary** As Staff Specialist Regulatory Affairs, you will have a deep understanding...changes to SaMD functionality and determine whether submissions or notifications are required. + Ensure SaMD compliance… more
- Abbott (Sylmar, CA)
- …requests for product release. + Reviews protocols and reports to support regulatory submissions . + Supports all business segment initiatives as identified ... submissions , progress reports, supplements, and amendments. *Interacts with regulatory agency to expedite approval of pending registration. *Serves as … more
- J&J Family of Companies (Santa Clara, CA)
- …+ In collaboration with cross-functional team members, compile, prepare, review and submit regulatory submissions to authorities in and outside the US (eg, EU, ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …pathways for new products; develops regulatory strategies and tactical plans for submissions regulatory bodies + Liaises with global RA lead(s), to ensure ... Demonstrated success in the preparation and completion (including negotiations) of regulatory submissions required + Demonstrated leadership skills +… more
- Kelly Services (South San Francisco, CA)
- …team members to maximize chances for first pass approval of IVD regulatory submissions , compliant with the appropriate regional or national regulations. ... **Kelly(R) Science & Clinical** is seeking a Regulatory Affairs Manager for a direct-hire position at...EU, USA, OUS; (Preferred experience: working experience with IVD submissions under IVDR Regulations is highly desirable) + Solid… more
- Oura (San Francisco, CA)
- …wearable-based health technology. + Provide strategic counsel on FDA oversight, regulatory submissions , and compliance strategies for biometric tracking, ... rights requests to ensure robust data privacy practices are integrated into regulatory submissions and compliance strategies. + Conduct internal audits and… more
- BeOne Medicines (San Mateo, CA)
- …This person will also provide strategic support for the preparation of regulatory submissions for advertising and promotional materials. Strong communication ... non-promotional medical, HEOR, and corporate/investor materials. + Supports preparation of regulatory submissions for advertising and promotional materials. +… more
- United Therapeutics (Sacramento, CA)
- …managing documentation and timelines, and supporting the preparation and execution of regulatory submissions for our whole organ tissue engineering program. Are ... the ESG portal + Proven track record in successfully navigating regulatory submissions + Proven ability to lead and influence data-driven strategy planning… more
- Kelly Services (Oakland, CA)
- …requirements. This position will be responsible for working cross-functionally to support key regulatory submissions as well as interfacing with regulatory ... expanded indications, including providing guidance for requirements and authorizing/reviewing regulatory filing documentation . Oversees/Manages submissions in… more