Clinical Regulatory Affairs Specialist 2
PCI Pharma Services(2 months ago)
About this role
PCI Pharma Services is hiring a Clinical Regulatory Affairs Specialist-2 to support regulatory compliance activities for clinical operations across multiple agencies, including FDA and DEA. The role centers on maintaining regulatory documentation and serving as a point of contact for audit-related interactions with current and prospective clients. This position is an individual contributor role without supervisory responsibility.
Required Skills
- Regulatory Compliance
- Audit Hosting
- CAPA Management
- SOP Writing
- Quality Agreements
- Site Master File
- Controlled Substances
- ARCOS Reporting
- DEA Registrations
- cGMP
+5 more
Qualifications
- Bachelor's Degree
About PCI Pharma Services
pci.comPCI is your world leading CDMO, providing integrated end-to-end drug development, manufacturing, and packaging solutions to increase product speed to market and opportunities for commercial success.
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