- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …Salary Range: Dependent on Qualifications/Experience Position Summary/Description: The purpose of Regulatory Associate is to facilitate the conduct of oncology ... clinical trial management system (OnCore) and eRegulatory binder (Florence). The Regulatory Associate also includes involvement in process improvements and… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- **Job Summary** **** The Associate Director, MSAT - Downstream provides specialized technical leadership and oversight for all downstream manufacturing processes ... review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. +… more
- Cambrex High Point (High Point, NC)
- …a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire ... career where You Matter by applying today! Job Overview The Senior Scientist, Regulatory Compliance will provide oversight of regulatory compliance activities to… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …and verbal). Has basic knowledge/understanding of domestic (ie Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines. ... (written and verbal). Demonstrated use of domestic (ie Food and Drug Administrations) and applicable foreign regulatory agency requirements/guidelines. Prior… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …skills (written and verbal). Demonstrated use of domestic (ie Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines. Be ... through Friday: 8:00 am to 5:00 pm **Sr. Quality Associate I / II / Principal, Quality Assurance:** The...regularly with members of management and as needed with regulatory officials. * Lead multi-disciplined project teams with highly… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines, including ... ** Associate Director, Small Molecule Analytical Development** + Lead...drug development lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards. **Competencies** **Accountability for Results… more
- IQVIA (Durham, NC)
- **Job Level: Associate /Director of Biostatistics,** **Rare Disease, FSP** **Location:** **Home-based in the US or Canada** **(East Coast Preferred)** **Job ... Overview:** As an Associate Director, you will liaise with cross-functional teams to...analysis, and reporting in support of pharmaceutical development and regulatory submissions. Serve as a resource for the department,… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Associate Director, Cleaning Validation is responsible for leading and executing Cleaning Validation (CV) activities for a large-scale ... biologics manufacturing facility in compliance with regulatory requirements, including 21 CFR Parts 11, 210, and 211, as well as ASTM E2500 guidelines. This role… more
- GRAIL (Durham, NC)
- …partnerships with pharmaceutical companies for companion diagnostic (CDx) tests. The Associate Director, Clinical Compliance will play a key leadership role in ... you'll collaborate cross-functionally to proactively manage both GCP and CDx regulatory risks, lead inspection readiness, and continuously improve quality standards… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …and services in more than 110 countries and regions. **The Clinical Research Associate assists in the management of the clinical monitoring process to ensure site ... adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols....to ensure data integrity. + Reconciles clinical supplies and drug accountability records at study sites. + Identifies and… more