Sr Regulatory Affairs - Labeling & Compliance (Remote)

Cardinal Health; Lansing (MI); Remote; USD 80,000 - 117,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

FlexPay

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health is seeking a Supervisor, Regulatory Affairs to lead regulatory programs ensuring compliance across drug, device, and cosmetic portfolios. You will oversee labeling approvals, listings, and FDA submissions while collaborating with QA, legal, and development teams.

The role emphasizes cross-functional leadership, Prop 65 review, and managing regulatory workflows to minimize risk and maintain supply chain integrity.

Qualifications

• Bachelor’s degree in a related scientific/technical field is required or equivalent experience.
• 4–8 years of pharmaceutical/medical device QA or regulatory affairs experience preferred.
• Private label experience is a plus for this role.

Responsibilities

• Coordinate labeling and listing activities and supervise specialists.
• Review and approve labeling components for private label brands.
• Oversee drug listing and FDA submissions, CARES Act reporting.
• Support quality systems, investigations, and market action workflows.

Skills

Regulatory affairs

Education

Bachelor’s degree in a related scientific/technical field

Tools

Kallik

FACTS

Veeva Vault QMS

Job description

Cardinal Health is seeking a Supervisor, Regulatory Affairs to lead regulatory programs ensuring compliance across drug, device, and cosmetic portfolios. You will oversee labeling approvals, listings, and FDA submissions while collaborating with QA, legal, and development teams.

The role emphasizes cross-functional leadership, Prop 65 review, and managing regulatory workflows to minimize risk and maintain supply chain integrity.