- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- … regulatory landscape. + Counseling on all aspects of product commercialization, including launch preparation, launch execution, market development, disease ... law. Possess a solid understanding of the biotech/pharmaceutical industry, including product development, commercialization, and the legal and regulatory … more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product… more
- Oracle (Albany, NY)
- …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 (Albany, NY)
- …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. (Albany, NY)
- **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
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- 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
- Lactalis American Group Inc. (Buffalo, NY)
- Quality Customer Relations Manager Buffalo, NY (http://maps.google.com/maps?q=2376+South+Park+Avenue+Buffalo+NY+USA+14220) Description Ready for more than just a ... of the Lactalis family of companies, is currently hiring a Quality Customer Relations Manager based in Buffalo, NY. The Quality Customer Relations Manager serves… more
- Chobani (New York, NY)
- …Testing and Validation: Execute performance testing, safety validation, and regulatory compliance verification with project manager coordination Technical ... Summary The Senior Manager , Mechanical Engineer will serve as the technical...work while mentoring 2-3 engineers and collaborating with creative, product , and project management teams. Working alongside our Industrial… more
- US Foods (Clifton Park, NY)
- …or product compromise. + Other duties as assigned by manager . **SUPERVISION** : + **Direct:** Maintenance and Sanitation Staff (Maintenance Technicians, Fleet ... teams, budgets, and vendor contracts. + Strong understanding of OSHA, EPA, USDA, FDA , GMP, and other regulatory compliance requirements. + Proficiency with CMMS… more
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