Remote Regulatory Affairs Supervisor

Cardinal Health; Helena (MT); Remote; USD 80,000 - 117,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

Paid time off

Job summary

Cardinal Health is seeking a Supervisor, Regulatory Affairs to lead regulatory programs across labeling, drug listing, and device submissions. You will ensure compliance with FDA standards and collaborate with QA, packaging, and development teams to maintain supply chain integrity.

The role emphasizes managing labeling components, Prop 65 assessments, and SOP refinements while navigating cross-functional workflows and external vendor collaborations.

Qualifications

• 4–8 years of experience in pharmaceutical/medical device Quality Assurance or Regulatory Affairs (Private Label experience preferred).
• Bachelor’s degree in a related scientific/technical field or equivalent practical work experience preferred.
• Familiarity with FDA compliance policies and USP standard testing; working knowledge of eDRLS and I4I/A4L software applications.

Responsibilities

• Coordinate and supervise labeling and listing approvals for CAH Pharmaceutical Private Label brands.
• Oversee drug listing activities and FDA submissions including CARES Act reporting and FDA Certification period.
• Lead cross-functional liaison between Quality, Packaging Operations, Commercial Product & Development, and external vendor QA groups.
• Update SOPs to tighten regulatory compliance and streamline processes.

Skills

Regulatory affairs

Quality Assurance

Regulatory 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 lead regulatory programs across labeling, drug listing, and device submissions. You will ensure compliance with FDA standards and collaborate with QA, packaging, and development teams to maintain supply chain integrity.

The role emphasizes managing labeling components, Prop 65 assessments, and SOP refinements while navigating cross-functional workflows and external vendor collaborations.