- Fujifilm (Research Triangle Park, NC)
- **Position Overview** The Director , QA Regulatory Affairs is a pivotal role providing regulatory expertise and leadership to the FUJIFILM ... procedures, offering strategic direction throughout the organization. Additionally, the Director leads a team of regulatory specialists...+ Leads, mentors, and sets the objectives for the Regulatory Affairs team across the North Carolina… more
- Cambrex High Point (High Point, NC)
- …in GXP/ QA / regulatory compliant pharmaceutical laboratory environment or Quality Assurance / Regulatory Affairs role (prefer late ... Change Requests, and Deviations in coordination with the Associate Director , Quality Assurance + Author...Knowledge of GMP manufacturing and analytical techniques to support QA and Regulatory process. Expertise in creating… more
- Bausch + Lomb (Raleigh, NC)
- …B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance , Pharmacovigilance/GPSS ... in an accurate and timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house team of CRAs, CTAs… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …+ Collaborate cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance , and ... **Associate Director , Small Molecule Analytical Development** + Lead and...the drug development lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards. **Competencies** **Accountability… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …cost reduction where appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance , Regulatory Affairs , and Operations ... **Position Overview:** The Senior Director , MSAT Biologics provides strategic and technical leadership...validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process… more
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