- Norstella (Raleigh, NC)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... requests into structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in ensuring our… more
- J&J Family of Companies (Wilson, NC)
- …in biopharmaceutical or pharmaceutical industry. + Working knowledge of regulatory requirements, policies and guidelines. Experience with Quality Control document ... reviews and regulatory inspection processes. + Working knowledge of laboratory systems....QC analytical equipment. + Knowledge of cGMP regulations and FDA /EU guidance. **Preferred** + An unquestionable level of integrity… more
- Deloitte (Charlotte, NC)
- …technologies like GenAI, AI/ML, and automation for analytical methods, manufacturing, regulatory and/or QA/QC + Implementation of regulatory authoring tool(s) ... ICH guidelines (ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA /EMA/PMDA regulations, and the structure/content of CMC sections in.../EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years… more
- ThermoFisher Scientific (Greenville, NC)
- … regulatory considerations governing adverse event reporting and experience with FDA , EMA and other national and international regulatory authorities + ... of clinical program and study design, relevant endpoints, safety considerations, and current regulatory and commercial landscape + Deep knowledge of important… more
- Lilly (Concord, NC)
- …least 4 years of supervisory or manager experience. + Understanding of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and OSHA, or other ... Environmental (HSE) functional groups + Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for related… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …practices. + Provides guidance as well as consults with manufacturing and internal regulatory departments on GXP matters. + Uses expertise and sound judgment to make ... in a timely manner and within projected budget. + Participates in regulatory and internal inspections/ audits including providing written responses as applicable for… more
- ThermoFisher Scientific (Greenville, NC)
- …software, and cleaning validation, ensuring compliance with industry standards and regulatory requirements. + Test Planning: Approve comprehensive test plans, test ... validation activities align with company policies, industry standards, and regulatory requirements. + Collaboration: Work closely with multi-functional teams,… more
- ThermoFisher Scientific (Greenville, NC)
- …while maintaining employee engagement, safety performance, and ensuring adherence to all regulatory control and documentation procedures. **This role will on a 2-2-3 ... changing priorities. . Ensures production operations are properly controlled and regulatory compliance requirements are met by ensuring batch documentation is… more
- Chiesi (Cary, NC)
- …newly created position will initially focus on pre-launch preparation in anticipation of FDA approval of our global market leading product, Trimbow(R). We want to ... of goals and an eye towards innovation. + Ensure compliance with regulatory , legal, and corporate requirements both separately and for respiratory patients +… more
- Chiesi (Cary, NC)
- …newly created position will initially focus on pre-launch preparation in anticipation of FDA approval of our global market leading product, Trimbow(R). We want to ... achievement of goals and an eye towards innovation. + Ensure compliance with regulatory , legal, and corporate requirements both separately and for asthma and copd… more