Clinical Regulatory Affairs Specialist

1h1 hour ago

PCI Pharma Services

US · Full-time · $62,960 – $70,830

About this role

PCI Pharma Services is seeking a Clinical Regulatory Affairs Specialist to oversee policies and objectives involving government and regulatory matters, including the FDA, DEA, MHRA, EEU, and State of Illinois. This role ensures company compliance with current Code of Federal Regulations and supports global impact for biopharma companies and their patients.

Day-to-day responsibilities include writing and implementing procedures, facilitating customer and regulatory auditing programs, and managing corrective actions from audits. The specialist also oversees controlled substance inventories for ARCOS reporting, reviews DEA-related investigations, and maintains Site Master Files and Clinical Customer Quality Agreements.

This position works closely with internal teams and external customers to ensure adherence to PCI, cGMP, and GCP policies. The role requires preparing and presenting monthly clinical metrics, submitting registration applications, and performing other duties as assigned by management.

PCI invests in people who make an impact and drive progress. This role offers the opportunity to shape regulatory compliance within a global network, with a base salary range of $62,960 to $70,830 plus eligibility for an annual performance bonus and a competitive benefits package.

Requirements

Bachelor's Degree in a related field and/or 1-5 years related experience and/or training
Basic mathematical skills
Intermediate computer skills with knowledge of various computer programs
Full professional proficiency in speaking, reading, and writing English
High reasoning ability to solve practical problems and interpret a variety of instructions
High standard of report writing
Ability to work independently and/or as part of a team
Ability to identify and resolve problems in a timely manner

Responsibilities

Write and implement procedures according to the current Code of Federal Regulations
Facilitate customer and regulatory auditing programs by completing 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 appropriate Site Master Files
Create, review, and maintain Clinical Customer Quality Agreements globally and site-specific
Write audit responses pertaining to customer and/or internal observations
Review investigations associated with DEA Controlled Products
Prepare and present monthly clinical metrics including customer-specific and overall departmental values