Remote Regulatory Affairs Supervisor

Cardinal Health; Honolulu (HI); Remote; USD 80,000 - 117,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401k plan

Paid time off

HSA

Job summary

Cardinal Health is seeking a Supervisor, Regulatory Affairs to lead labeling approvals, drug listing activities, and FDA submissions on a nationwide remote basis. The role requires 4–8 years of regulatory/QA experience and a strong grasp of FDA guidelines and QMS tools.

You will oversee a team, enforce policy adherence, and collaborate with Quality, Packaging, and Development to ensure compliance across medical products. A bachelor’s degree and strong communication skills are essential.

Qualifications

• 4–8 years of experience in pharmaceutical/regulatory affairs or QA, preferably private label.
• Bachelor’s degree in a related scientific/technical field or equivalent.
• Familiarity with FDA policy guides, 21 CFR Part 11, USP standards.
• Knowledge of Kallik, FACTS, or Veeva Vault QMS database architectures.
• Experience with eDRLS and I4I/A4L software for FDA listings.

Responsibilities

• Coordinate and supervise daily activities of labeling and listing specialists.
• Administer and enforce internal policies to support regulatory objectives.
• Collaborate with QA, packaging ops, product development, and external QA vendors.
• Oversee drug listing activities and FDA submissions (CARES Act reporting).
• Manage SOPs to tighten compliance and streamline processes.
• Lead cross-functional alignment and quality agreements.

Skills

Regulatory compliance

Labeling approvals

FDA knowledge

Cross-functional leadership

Education

Bachelor’s degree

Tools

Kallik

Veeva Vault QMS

GUDID

Job description

Cardinal Health is seeking a Supervisor, Regulatory Affairs to lead labeling approvals, drug listing activities, and FDA submissions on a nationwide remote basis. The role requires 4–8 years of regulatory/QA experience and a strong grasp of FDA guidelines and QMS tools.

You will oversee a team, enforce policy adherence, and collaborate with Quality, Packaging, and Development to ensure compliance across medical products. A bachelor’s degree and strong communication skills are essential.