Clinical Regulatory Affairs Specialist

Responsibilities

• Write and implement procedures in accordance with the current Code of Federal Regulations
• Ensure company policies are properly followed and applied by all appropriate personnel
• Facilitate the Customer and Regulatory auditing program, including pre-audit documentation, hosting audits, and developing corrective actions
• Oversee regular inventories of Controlled Substances for ARCOS reporting and required inventory reports
• Review and maintain Site Master Files and Clinical Customer Quality Agreements
• Manage and monitor Audit Corrective Actions and write audit responses
• Review investigations associated with DEA Controlled Products
• Submit applicable registration applications and prepare monthly Clinical metrics

Requirements

• Bachelor's Degree in a related field and/or 1-5 years of related experience and/or training
• High standard of report writing and full professional proficiency in written and spoken communication
• Intermediate computer skills with the ability to perform complex tasks across various programs
• Basic mathematical skills
• High reasoning skills with the ability to solve practical problems and interpret various instructions

Preferred Qualifications

• Ability to work independently and as part of a collaborative team
• Strong attention to detail
• Proven ability to identify and resolve problems in a timely manner
• Professional demeanor and conduct

Benefits

• Competitive base salary with eligibility for an annual performance bonus
• Paid time off
• Health insurance coverage, including dental and vision
• Flexible spending account
• 401(k) retirement plan

About the Company

PCI Pharma Services is a global provider of clinical and commercial drug development and manufacturing services. We act as a bridge between life-changing therapies and the patients who need them, focusing on quality, operational excellence, and an industry-leading customer experience.