- Reynolds American (Winston Salem, NC)
- …Experience in global regulatory environments and familiarity with frameworks such as FDA and evolving standards (REACH , ISO, OECD). + Strategic mindset with the ... US Life Sciences, Product Development and Deploy, and Scientific and Regulatory Affairs, embedding toxicological considerations throughout the product lifecycle and… more
- United Therapeutics (Morrisville, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... SOPs, test methods, and product specifications to ensure alignment with regulatory requirements, internal quality standards, and industry best practices + Review… more
- Norstella (Raleigh, NC)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... therapeutic research and industry trend analysis, including competitive positioning, regulatory changes, domain-specific insights, and opportunities + Drive innovation… more
- FST Technical Services (Holly Springs, NC)
- …teams. + Ensure all work complies with project drawings, specifications, codes, and regulatory requirements (eg, ASME, cGMP, FDA , ISO). Quality Oversight + ... managing budgets, schedules, and multi-disciplinary teams. + Familiarity with cGMP, FDA , and ASME B31.3 or equivalent standards. Certifications (Preferred) + PMP,… more
- Lilly (Concord, NC)
- …effectively with a cross functional group. + Solid understanding of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and/or OSHA. + ... functional groups + Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert...4+ years in supervisory role + cGMP standards and FDA (or other industry) guidelines for production + Aseptic… more
- Fujifilm (Holly Springs, NC)
- …will maintain quality systems that align with CGMP, GDP, and other regulatory standards, ensuring product compliance through robust quality systems. You will play ... across the Holly Springs, NC site, ensuring alignment with organizational goals and regulatory requirements. Join us and take your career to the next level in… more
- Oracle (Raleigh, NC)
- …with engineering and compliance teams to ensure process efficiency, regulatory alignment, and continuous improvement throughout the software development lifecycle ... We are looking for someone with demonstrated awareness of regulatory standards and hands-on experience integrating regulatory ...of healthcare regulations and standards relevant to software (eg FDA 21 CFR Part 820, ISO 13485:2016, EU MDR)… more
- Merck (Raleigh, NC)
- …Maintain training materials in compliance with applicable SOPs, policies, and regulatory requirements. + Defines and contributes to the development of training ... trial processes, including relevant standards and documentation. + Familiarity with FDA Good Clinical Practices, ICH Guidelines, and other major regulatory… more
- ITG Brands (NC)
- …(EOL), to ensure delivery of business objectives. Accountable for ensuring US Regulatory & Compliance requirements are met for all specifications across all Company ... Lead team functioning as point of contact for US regulatory product compliance for all US marketed products and...Must be 21 years of age or older + FDA regulated industry Knowledge of: + Advanced proficiency with… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized ... with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global...requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience… more