- 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
- LSI Solutions (Victor, NY)
- …complaint handling system, and assisting with the procurement of domestic and international regulatory approval for new and revised product lines, helping to ... Do you have experience as an administrative professional, office manager , or clerical assistant? This may be an opportunity...that skillset and branch out into the area of regulatory . We are seeking a person who is highly… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- 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
- Oracle (Albany, NY)
- …Body audits, and SOC2/ISO reviews. + Serve as a primary quality partner during regulatory assessments. ** Regulatory & Product Partnership** + Partner with ... Description** Oracle Health Data Intelligence is hiring a **Quality Manager ** to lead and mature our quality systems and...Regulatory Scientists, Engineering, Product , and Security to ensure submissions and technical documentation… more