- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is... submissions, and post-marketing lifecycle management as the CMC Regulatory lead . + Regulatory experience… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead . Translates complex pertinent global ... submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need and obtains … more
- AbbVie (Irvine, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Strategic Global Labeling Manager in Regulatory Affairs is responsible ... in accordance with internal labeling procedures. + Maintain documentation within regulatory information management system. + Co- lead cross-functional labeling… more
- LinkedIn (Mountain View, CA)
- …a Governance, Risk and Compliance Manager with expertise in legal and regulatory compliance to join our Global Compliance and Integrity team. This role ... risk appetite. The ideal candidate will bring a strong understanding of global regulatory frameworks and demonstrate experience translating legal requirements… more
- ThermoFisher Scientific (Carlsbad, CA)
- …is safe or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager , Regulatory Affairs, you will play a crucial role in interpreting and ... Life:** + Interpret and communicate the impact of relevant global regulations, guidelines, and evolving regulatory trends...in the area of cell and gene therapy. + Lead maintenance and improvements to regulatory tools,… more
- Oracle (Sacramento, CA)
- …workflows in alignment with US federal/state and international regulations. + **Shape global regulatory content development** : Translate regulatory and ... **The Role** We are seeking a **Senior Principal Product Manager ** who deeply understands the ** regulatory , clinical,...(eg, CMS, ACOs, value-based care), as well as international regulatory frameworks. In this role, you will lead… more
- J&J Family of Companies (Irvine, CA)
- …lifecycle activities, coordinate with cross-functional teams, and ensure adherence to global regulatory standards. This role involves direct supervision of ... We are searching for the best talent for a ** Manager , Regulatory Affairs** . _The preferred location...demonstrated track record of developing and driving implementation of regulatory strategies. + Working knowledge of how global… more
- Abbott (Pleasanton, CA)
- …mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager ** to join Abbott's Heart Failure Division on-site ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge...You'll Work On** ** Regulatory Knowledge/Skills:** + Anticipate regulatory obstacles and emerging issues. + Lead … more
- Parexel (Sacramento, CA)
- …guidance of the Regulatory CMC Lead , develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key ... patients. We are currently seeking a dedicated and detail-oriented ** Regulatory CMC Project Manager ** to join a... CMC activities for the program, ensuring alignment with global regulatory requirements. Project Management: Serve as… more
- Meta (Burlingame, CA)
- … regulatory readiness projects to ensure Reality Labs products comply with global regulatory requirements 3. Build, scale, and optimize compliance programs ... the future with Trust in mind.We are seeking an experienced Manager and industry expert in regulatory compliance programs, with a track record of standing up new… more