Remote Regulatory Affairs Supervisor – Labeling & Compliance

Cardinal Health; Boise (ID); Remote; USD 80,000 - 117,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

401k plan

HSA

Paid time off

Job summary

Cardinal Health seeks a Supervisor, Regulatory Affairs to oversee labeling approvals, listing activities, and regulatory workflows across drug, device, and cosmetic portfolios. You will guide cross-functional teams to maintain compliance and minimize regulatory risks.

Responsibilities include supervising specialists, ensuring SOP adherence, and coordinating with QA, packaging operations, and development. A strong FDA/regulatory background and private label experience are preferred.

Qualifications

• Experience: 4–8 years in pharmaceutical/medical device QA or regulatory affairs (private label preferred).
• Education: Bachelor’s degree in a related scientific/technical field or equivalent practical experience.
• Preferred knowledge: FDA compliance policy guides (CPGs), 21 CFR Part 11, USP standards.
• Systems: familiarity with Kallik, FACTS or Veeva Vault QMS; working knowledge of eDRLS and I4I/A4L for FDA submissions.

Responsibilities

• Coordinate and supervise labeling and listing activities.
• Oversee QA approvals of labeling components for private label brands.
• Review Prop 65 assessments to ensure marketing compliance.
• Manage drug listing activities and FDA submissions support.
• Lead cross-functional alignment and regulatory liaison activities.

Skills

FDA Compliance Knowledge

Regulatory Submissions

Education

Bachelor’s degree in a related scientific/technical field

Tools

Kallik

FACTS

Veeva Vault QMS

eDRLS

I4I/A4L

Job description

Cardinal Health seeks a Supervisor, Regulatory Affairs to oversee labeling approvals, listing activities, and regulatory workflows across drug, device, and cosmetic portfolios. You will guide cross-functional teams to maintain compliance and minimize regulatory risks.

Responsibilities include supervising specialists, ensuring SOP adherence, and coordinating with QA, packaging operations, and development. A strong FDA/regulatory background and private label experience are preferred.