- Sumitomo Pharma (Harrisburg, PA)
- …ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + ... and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health.… more
- Newell Brands (Harrisburg, PA)
- …a related field. + 3-5 years of experience in tax incentives, government programs, regulatory affairs , or a related area (internships or co-op experience may be ... in the successful execution of incentive strategies and compliance with regulatory requirements. **Key Responsibilities** + Conduct research on government incentive… more
- UPMC (Monroeville, PA)
- …and ID badge at all times. + Follows all radiation safety standards. + Regulatory Affairs Management: Participates in regulatory compliance activities and ... Involvement in each of the following areas: Administration/Management, Education/International, Quality/ Regulatory , and Billing/Coding.Licensure, Certifications, and Clearances:ARRT Registration in good… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …outcomes. + **Cross-Functional Collaboration** + Collaborate with Procurement, Manufacturing, Regulatory Affairs , and Technical Operations to ensure supplier ... issues. + **Compliance & Documentation** + Ensure supplier compliance with global regulatory requirements (eg, FDA, EMA, ICH). + Prepare documentation and support… more
- J&J Family of Companies (Spring House, PA)
- …Leadership, Medicines and Device Development and Regulation, Performance Measurement, Regulatory Affairs Management, Resource Planning, Risk Management, ... Execution: Apply an agile, entrepreneurial approach to navigate scientific, regulatory , and organizational uncertainty, ensuring delivery against strategic priorities.… more
- Charles River Laboratories (Wayne, PA)
- …biological lab. + _Certification/Licensure:_ None + _Other:_ Knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries ... Testing Solutions With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for… more
- dsm-firmenich (Exton, PA)
- …of career paths within Quality, with exposure to QC, QA, Supplier Quality, Regulatory Affairs , and Quality Engineering to inform future professional goals. ... maintain ISO 13485 compliant files. + Contribute to Product Release and Regulatory tasks, such as batch record reviews, technical file updates, labelling checks,… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …**Global Collaboration & Stakeholder Engagement** + Partner with stakeholders across Regulatory Affairs , Clinical, Manufacturing, Compliance, and IT to align ... excellence roles. + Solid understanding of GxP principles and global regulatory expectations. + Experience supporting audit or inspection readiness programs. +… more
- UPMC (Greensburg, PA)
- …Assists at other UPMC Radiation Oncology locations if the need arises. + ** Regulatory Affairs Management** : Participates in regulatory compliance activities ... and maintains continuous departmental readiness for inspections and surveys. Follows all radiation safety standards. Wears radiation monitoring badge and ID badge at all times. Remains HIPAA compliant at all times. Completes clinical competencies annually as… more
- UPMC (Farrell, PA)
- …in the administration of contrast agents used during treatment localization. + Regulatory Affairs Management:Participates in regulatory compliance activities ... and maintains continuous departmental readiness for inspections and surveys.Follows all radiation safety standards.Wears radiation monitoring badge and ID badge at all times.Remains HIPAA compliant at all times. Completes clinical competencies annually as… more