- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed ... lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides… 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 ... for developing and delivering patient-centered global product labeling for the safe and effective use of AbbVie products. The key responsibilities include leading… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing ... global regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes… more
- System One (Novato, CA)
- …organization focused on innovative global therapeutic development is seeking a Regulatory Affairs Manager to support their nonclinical and clinical ... Job Title: (CW) Regulatory Affairs Manager Location: Novato, CA...regulatory programs. This role is essential in shaping regulatory strategy, preparing global submissions, and ensuring… more
- Actalent (Lake Forest, CA)
- Description We are seeking an experienced and strategic Regulatory Affairs Manager to support global regulatory submissions and compliance activities. ... lifecycle management. Key Responsibilities: - Development and execution of regulatory strategies for New Product Development and sustaining engineering projects… more
- Ascendis Pharma (Palo Alto, CA)
- …skills. The Regulatory Project Manager will be an integral part of Global Regulatory Affairs, providing project management leadership to key global ... regulatory submissions across the Ascendis pipeline. As a part of the Global Regulatory Affairs team, you will be responsible for contributing to the vision,… more
- AbbVie (Irvine, CA)
- …(R&D) organizations. Represents RA Device on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, ... present data and strategy to regulatory agencies. + Responds to global regulatory information requests. + Develops strategies for device agency meetings,… 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)
- …to all Good Manufacturing Practices (GMP) Safety Standards, Office **Job Description** The Sr. Manager , Regulatory Affairs - Drug Support Strategy is a new role ... as well as customer and employee needs. The Sr. Manager will develop and pursue world-class regulatory ...the Life:** + Interpret and communicate impact of relevant global regulations, guidelines and evolving regulatory trends.… 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,...operations** , care delivery, and payer programs. + Enable ** global and US regulatory content and policy… more