- Bristol Myers Squibb (San Diego, CA)
- …experience in the biotech, pharmaceutical or life sciences industry, including significant FDA regulatory and healthcare law counseling. + Prior experience ... legal advice to RayzeBio's leadership and cross-functional teams, including R&D, regulatory , medical, manufacturing, quality , supply chain, and commercial… more
- Novo Nordisk (Plainsboro, NJ)
- …within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... Operations, Commercial, NNI IT and Telephony, Medical Information, Product Safety, Regulatory , Quality , Legal, Privacy and Finance. External relationships… more
- Merck (West Point, PA)
- …will ensure products and processes are developed in accordance with applicable regulatory , quality , company, and customer requirements. This position will lead ... + Knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human… more
- ThermoFisher Scientific (Lenexa, KS)
- …(if applicable): Day; M-F 8:00 AM to 5:00 PM **Position Summary:** The Quality Control Supervisor is responsible for leading all aspects of the daily operations ... of the Quality Control laboratory, ensuring that all processes and products...that all processes and products meet established standards and regulatory requirements. This role involves managing a team of… more
- Sanofi Group (Morristown, NJ)
- … regulatory authorities. You'll collaborate across R&D, Device, Manufacturing, and Quality teams while preparing high- quality regulatory submissions, ... relationships with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Manufacturing… more
- US Foods (Rosemont, IL)
- …support, and develop a team of FSQA professionals addressing food safety, quality , and regulatory issues across assigned product categories (Grocery, COP, ... to maintain product specifications to ensure consistent adherence to food safety, quality , and regulatory requirements. This requires teaming up with the… more
- Bristol Myers Squibb (Manati, PR)
- …process validation, clinical lot troubleshooting, and ongoing process optimization. 9. Regulatory & Quality Support Supports regulatory submissions, ... parenteral product manufacturing processes, including aseptic techniques.** + **Proficient in regulatory compliance, including cGMPs , FDA regulations, and… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we ... collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across… more
- Bristol Myers Squibb (Devens, MA)
- …that all work complies with company policies, EHS safety procedures, and regulatory requirements ( FDA , OSHA, EPA). + Collaborates with multidisciplinary teams ... Mechanical equipment. + Ability to read and interpret technical documents, schematics, and regulatory guidelines. + Familiarity with GMP, FDA , and other … more
- University of Miami (Miami, FL)
- …the primary investigator and project team to assist in responding to queries from regulatory agencies including the FDA . + Tracks proposals and other study ... This role is also responsible for the independent execution of regulatory -related decisions/strategies and coordinates work with study managers and other relevant… more