Remote Regulatory Affairs Supervisor

Cardinal Health; Hartford (CT); Remote; USD 80,000 - 117,000; Full time

Benefits offered by this job

Medical/dental/vision

Paid time off

HSA

401k

MyFlexPay

FSAs

Disability insurance

Work-Life resources

Paid parental leave

Lifestyle programs

Job summary

Cardinal Health is seeking a Supervisor, Regulatory Affairs to oversee labeling approvals and regulatory workflows across drug, device, and cosmetic portfolios. The role emphasizes collaboration with QA, packaging, and development teams to maintain federal and state compliance.

The ideal candidate will have 4–8 years in pharma/medical device regulatory affairs, a bachelor’s degree in a scientific field, and hands-on experience with FDA submissions and QMS systems.

Qualifications

• Bachelor’s degree required or equivalent practical work experience.
• 4–8 years of pharma/medical device QA or Regulatory Affairs experience.
• Familiarity with FDA policy guides (CPGs) and 21 CFR Part 11.
• Experience with Kallik, FACTS, or Veeva Vault QMS.
• Knowledge of FDA drug listing submissions and regulatory databases.

Responsibilities

• Oversee labeling approvals for CAH Private Label brands.
• Review and approve Master Batch Records labeling sections and re-packaging requests.
• Review Prop 65 claims and California assessments for marketing material compliance.
• Manage Drug Listing, CARES Act reporting, FDA certifications, and GUDID submissions.
• Lead cross-functional coordination with QA, Packaging Operations, Product Development, and external QA groups.

Skills

Regulatory compliance

Cross-functional collaboration

Documentation control

FDA regulations

Quality systems

Education

Bachelor’s degree in scientific/technical field

Tools

Kallik

FACTS

Veeva Vault QMS

eDRLS

I4I/A4L

Job description

Cardinal Health is seeking a Supervisor, Regulatory Affairs to oversee labeling approvals and regulatory workflows across drug, device, and cosmetic portfolios. The role emphasizes collaboration with QA, packaging, and development teams to maintain federal and state compliance.

The ideal candidate will have 4–8 years in pharma/medical device regulatory affairs, a bachelor’s degree in a scientific field, and hands-on experience with FDA submissions and QMS systems.