Remote Regulatory Affairs Supervisor

Cardinal Health; Olympia (WA); Remote; USD 80,000 - 117,000; Full time

Job summary

Cardinal Health is seeking a Supervisor, Regulatory Affairs to manage regulatory programs, policies, and procedures ensuring compliance across labeling, drug listing, and device submissions. You will coordinate labeling and listing activities, train specialists, and collaborate with QA, legal, and vendor groups.

You bring 4–8 years of pharmaceutical/medical device QA or regulatory affairs, a Bachelor’s in a scientific field, and experience with Kallik, FACTS, or Veeva Vault QMS.

Qualifications

• Experience: 4–8 years of experience in pharmaceutical/medical device Quality Assurance or Regulatory Affairs (Private Label experience preferred).
• Education: Bachelor’s degree in a related scientific/technical field, or equivalent practical work experience preferred.
• Preferred Technical Knowledge: 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

• Coordinate and supervise labeling and listing activities.
• Oversee QA approvals of labeling components for Private Label brands.
• Review and approve packaging labeling sections in MBRs and Repackaging requests.
• Review California Proposition 65 assessments and ensure marketing material compliance.
• Oversee Drug Listing submissions, CARES Act reporting, and FDA Certification periods.
• Lead cross-functional regulatory liaison with QA, Packaging Operations, Product Development, and external vendor QA groups.

Skills

Regulatory Affairs

Quality Assurance

FDA compliance

Education

Bachelor's degree in a related scientific/technical field

Tools

Kallik

FACTS

Veeva Vault QMS

eDRLS

I4I/A4L

Job description

Cardinal Health is seeking a Supervisor, Regulatory Affairs to manage regulatory programs, policies, and procedures ensuring compliance across labeling, drug listing, and device submissions. You will coordinate labeling and listing activities, train specialists, and collaborate with QA, legal, and vendor groups.

You bring 4–8 years of pharmaceutical/medical device QA or regulatory affairs, a Bachelor’s in a scientific field, and experience with Kallik, FACTS, or Veeva Vault QMS.