- Grifols Shared Services North America, Inc (Clayton, NC)
- … regulatory experience. + Minimum 5 years of related technical and/or regulatory experience in pharmaceutical industry or an equivalent combination of ... validation, environmental monitoring, cGMP manufacturing, QA/QC for biological products, compliance and/or regulatory is required. + Excellent written… more
- ICON Clinical Research (NC)
- Senior Manager , Regulatory Affairs - IVD ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an ... to join us on our mission to shape the future of clinical development. Sr Manager , Regulatory Affairs - IVD Location: US Remote, Portland, OR area preferred We… more
- ThermoFisher Scientific (Greenville, NC)
- …Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** Join us as a Program Manager within our Regulatory Medical Writing team where you will ... of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700...makes a real difference in organizational performance. As a Regulatory Medical Writing Program Manager , you will… more
- Parexel (Raleigh, NC)
- …* Work on impactful global programs that directly support patient safety and regulatory compliance . * Collaborate with a diverse, international team across ... Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large,...EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting… more
- Chiesi (Cary, NC)
- …quo for the better. Who we are looking for This is what you will do The Compliance Manager - Monitoring, Auditing, and Risk plays a crucial role in ensuring that ... + Audit Management: Complete, oversee, and/or manage internal audits to ensure compliance with company policies, regulatory requirements, and industry standards.… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of ... **Job Summary** The Manager , Global Product Quality - Controlled Substances is...and oversight of suppliers/contract manufacturers.Act as a liaison with regulatory agencies and internal compliance teams regarding… more
- United Therapeutics (Research Triangle Park, NC)
- …comprehensively support ongoing pricing and contracting operations for all of the Company's pharmaceutical products. The Manager will serve as a key contributor ... are as follows:** Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit… more
- Sumitomo Pharma (Raleigh, NC)
- …procedures (SOPs) across PV operations and quality systems to ensure consistency, regulatory compliance , and operational excellence. + Support global safety ... inspection preparedness, and cross-functional initiatives to ensure operational excellence and regulatory adherence. The Senior Manager works closely with the… more
- Chiesi (Cary, NC)
- …Assess change controls for potential impact to validated state, data integrity, and regulatory compliance , and ensure appropriate CSV activities are defined and ... you will do This position ensures Chiesi USA, Inc.'s compliance with cGMP, CSV, and data integrity standards by...product for the US market with little to no Manager assistance. + Review and approve product-related documents (eg,… more
- J&J Family of Companies (Wilson, NC)
- …**QA Specialist, Compliance ** This position is responsible for ensuring compliance with regulatory requirements and company policies following current Good ... required. + Minimum six (6) years experience working within the biological and/or pharmaceutical industry in a quality, manufacturing, or compliance role. +… more
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