JobMesh

Clinical Regulatory Affairs Specialist 2

PCI Pharma Services · Springfield, Illinois, US

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Position Title: Clinical Regulatory Affairs Specialist II Location: Assembly Drive, Rockford: Shift: First Shift: The Clinical Regulatory Affairs Specialist-2 oversees the company's policies and objectives involving matters of government and regulations, with respect to the FDA, DEA, MHRA, EEU, State of Illinois, and other regulatory agencies. This position hosts audits for current and prospective clients. This position does not have any supervisory responsibilities. Essential Duties and Responsibilities: Write and implement procedures according to the current Code of Federal Regulations. Assure that company policies are properly followed and applied by all appropriate personnel. Assists the Regulatory Affairs Manager by hosting audits, developing appropriate corrective actions documented through the audit reports and ensuring proper implementation. Oversee regular inventories...