- Unknown (San Diego, CA)
- …international submissions. The role also involves supporting all aspects of global commercial product regulatory affairs. The VP will be accountable for ... Vice President, Regulatory Affairs, Oncology About the Company Globally-recognized pharmaceutical...teams, and ensuring the compliance of promotional materials with FDA regulations and company policies. Applicants for the Vice… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …drug products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting ... strategies for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting… more
- Oracle (Sacramento, CA)
- …our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into ... for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- Oracle (Sacramento, CA)
- …our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into ... for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Job Summary** The Manager , Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances ... (CGMP) regulations, Otsuka Quality Standards and US/global (if applicable) regulatory requirements. **Key Responsibilities** + Product Oversight: Provide… more
- Actalent (Fresno, CA)
- …organizations where we do business. Ability to act as a back up to the Regulatory Manager as needed. Performs other related and assigned duties by senior ... up, customer product database set up etc). Review and approve healthcare/nutrition product claims to ensure compliance with FDA , FTC, and other applicable… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract ... and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized… more
- Unilever (San Francisco, CA)
- …and future acquisitions to come! This position's home company is OLLY. THE ROLE: PRODUCT INNOVATION MANAGER Reporting to the Director of Innovation of VMS, you ... opportunity in supporting shape the VMS-Co-Op pipeline. As a Product Innovation Manager , you will play a...science, Chemistry, or related science field + Familiarity with FDA guidelines for dietary supplementation and regulatory … more
- Danaher Corporation (Vista, CA)
- …if you also possess previous experience in: + Experience with regulatory landscapes ( FDA , CE, etc.) and clinical product launches. + 5+ years product ... impact. Learn about the Danaher Business System which makes everything possible. As a Product Manager of our Digital Pathology portfolio, you'll sit at the… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- The ** Manager , Manufacturing Product Quality (Small molecule)** is responsible for ensuring **GMP compliance** in the manufacturing packaging, labeling, and ... and at external vendors, ensuring that quality standards are met and regulatory requirements are maintained throughout the commercial and clinical supply chains. The… more
