Clinical Regulatory Affairs Specialist 2
PCI Pharma Services(6 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 global agencies. The role serves as a key regulatory point of contact for audits and quality/regulatory documentation within a biopharma services environment. The position is an individual contributor role with no direct supervisory responsibility.
Required Skills
- Regulatory Compliance
- cGMP
- GCP
- FDA Regulations
- DEA Compliance
- Audit Hosting
- Corrective Actions
- SOP Writing
- Quality Agreements
- Site Master File
+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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