Supervisor, Reg Affairs

Cardinal Health

6d•$79,700 - $117,200

About The Position

The Supervisor, Regulatory Affairs manages regulatory programs, policies, and procedures to minimize risk and protect supply chain integrity. The role applies regulatory expertise and technical capabilities to resolve complex issues in partnership with cross-functional teams, ensures organizational alignment with new and revised standard operating procedures, and monitors adherence to policies. The supervisor coordinates and oversees the daily work of labeling and listing senior specialists and reinforces internal policies and procedures in support of quality and regulatory objectives. The role also works with senior leaders, vendor quality assurance, and legal groups on information exchange, complex problem resolution, and cross-functional consensus. Responsibilities span labeling and packaging approvals, drug and device listing operations, quality investigations and market-action support, regulatory systems and database integrity, process improvement, and team leadership. The position serves as a primary regulatory liaison across internal business functions and external vendor quality groups.

Requirements

4–8 years of experience in pharmaceutical or medical device Quality Assurance or Regulatory Affairs.
Bachelor’s degree in a related scientific or technical field, or equivalent practical work experience, preferred.

Nice To Haves

Private Label experience.
Familiarity with FDA Compliance Policy Guides (CPGs), 21 CFR Part 11, and USP standard testing.
Experience with Kallik, FACTS, or Veeva Vault QMS database architectures.
Working knowledge of eDRLS and I4I/A4L software applications for FDA drug listing submissions.

Responsibilities

Oversee and assist with quality assurance approvals of labeling components for Cardinal Health Pharmaceutical Private Label brands.
Review and approve labeling sections of Master Batch Records and requests for repackaging.
Review and approve claims, bio-food statements, and California Proposition 65 assessments for marketing material compliance.
Oversee proofing and disposition of Package Insert revisions.
Partner with quality assurance managers to resolve complex packaging and labeling deviations.
Lead efforts to obtain defect photographs and complaint samples, and establish root-cause scope to define market-action limits.
Facilitate and draft Health Hazard Evaluations in collaboration with clinical medical safety experts to support potential market-action workflows.
Oversee drug listing activities for Cardinal Health Pharmaceutical Private Label products and provide guidance and review for accurate, timely FDA submissions, including CARES Act reporting and FDA certification periods.
Manage Medical Device Unique Device Identification data submissions to GUDID and maintain regulatory labeling workflows in the Kallik management system.
Regularly update Standard Operating Procedures to strengthen regulatory compliance and improve process efficiency and quality.
Direct, supervise, and mentor Specialists and Senior Specialists within Quality Assurance and Regulatory Compliance teams.
Act as a primary regulatory liaison among Quality, Packaging Operations, Commercial Product & Development, Pharmaceutical Product Sourcing, and external vendor quality assurance groups.
Lead collaborative discussions about Quality Agreements to ensure strategic external alignment.
Administer and reinforce internal policies and procedures supporting quality and regulatory objectives.