- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …executes professional presentations to donors to include, but not limited to the C-suite, Regulatory Affairs, Quality and R & D departments (and their respective ... or testing of raw materials that are included in FDA approved products/processes as well as with internal USP...engagement (including sales) experience a plus. + Experience with regulatory compliance, quality control, quality … more
- Cambrex High Point (Charles City, IA)
- …biotech, or other regulated manufacturing environment. + Demonstrated knowledge of cGMP, FDA regulatory guidelines, and industry best practices. + Experience ... manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career...the Operations training program in alignment with corporate and regulatory requirements ( FDA , DEA, OSHA, etc.). +… more
- J&J Family of Companies (Titusville, NJ)
- …Team. Team matrix interactions may include project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, ... TA strategy, regulatory affairs, data management, medical writing, biostatistics, global medical...team and be responsible for timely completion, content and quality of key documents eg clinical development plans, protocol… more
- J&J Family of Companies (Danvers, MA)
- …software, and clinical engineers while collaborating with cross-functional partners in Quality , Regulatory , Manufacturing, and Supply Chain. You will translate ... methods; summarize results and provide actionable technical conclusions. + Coordinate with Quality and Regulatory to prepare verification packages for … more
- Hologic (Newark, DE)
- …device process and/or product development environment. **Skills:** + Experience with FDA Quality Systems Regulation, especially Design Control requirements, ISO ... for verification/validation activities. + Maintain accurate records and documentation per FDA and other regulatory requirements. + Interact with internal… more
- Otsuka America Pharmaceutical Inc. (Richmond, VA)
- …the design, implementation, and governance of global learning strategies that support regulatory readiness, operational excellence, and a strong quality culture. ... execute the global GxP training strategy in alignment with regulatory requirements and corporate quality objectives. +...Risk Management** + Ensure all training programs meet global regulatory standards ( FDA , EMA, ICH, etc.) and… more
- Genentech (South San Francisco, CA)
- …pharmaceutical, biotech, or CRO settings. + You are familiar with ICH guidelines, GCP, and regulatory requirements such as FDA and EMA. + You have a strong ... innovative clinical trials, apply rigorous statistical methods, and implement high- quality programming and analytical solutions to accelerate timelines, de-risk… more
- UTMB Health (Galveston, TX)
- …funding agencies to design and execute regulated nonclinical studies compliant with the US FDA GLP regulations or under quality systems that utilize the US ... Select Agent Program (FSAP). **JOB SUMMARY** **Function** : The Regulatory Scientist II will be assigned as a Study...FDA GLP regulations as a reference standard. The Regulatory Scientist II may also function as a Principal… more
- Actalent (Watertown, CT)
- …development process. + Provide training to team members and other departments on quality standards, testing procedures, and regulatory compliance. + Create and ... CT Job Description This specialized role requires a focus on regulatory compliance, rigorous testing procedures, and meticulous documentation to ensure that… more
- Reckitt (Evansville, IN)
- …cross-functional teams ( Quality , Operations, HR, EHS) to ensure training programs meet FDA and other regulatory standards. + Partner with Supply and HR ... in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not...and capabilities required to operate in a highly regulated, FDA -compliant environment. The successful candidate will oversee the development… more