Remote Regulatory Affairs Supervisor: Labeling & Compliance

Cardinal Health; Dover (DE); Remote; USD 80,000 - 117,000; Full time

Benefits offered by this job

Medical benefits

PTO

HSA

401k

Wage access via myFlexPay

FSAs

Disability coverage

Work-Life resources

Parental leave

Job summary

Cardinal Health is seeking a Supervisor, Regulatory Affairs to oversee labeling and drug/device listings, ensuring regulatory compliance across portfolios. You will lead a team of specialists and collaborate with QA, packaging, and development groups.

Responsibilities include managing labeling approvals, ensuring Prop 65 compliance, maintaining FDA submissions, and refining SOPs to improve process efficiency and quality across private label and commercial products.

Qualifications

• 4–8 years of experience in pharmaceutical/medical device QA or Regulatory Affairs.
• Bachelor’s degree in a related scientific/technical field.
• Familiarity with FDA Compliance Policy Guides (CPGs), 21 CFR 11, and USP testing.

Responsibilities

• Coordinate and supervise the daily activities of labeling and listing specialists.
• Oversee QA approvals of labeling components and packaging sections.
• Review Prop 65 assessments and ensure marketing material compliance.
• Update SOPs and ensure alignment with regulatory requirements.

Skills

Regulatory affairs

Quality Assurance

FDA compliance

GxP knowledge

Education

Bachelor's degree in science/technical field

Tools

Kallik

FACTS

Veeva Vault QMS

eDRLS

I4I/A4L

Job description

Cardinal Health is seeking a Supervisor, Regulatory Affairs to oversee labeling and drug/device listings, ensuring regulatory compliance across portfolios. You will lead a team of specialists and collaborate with QA, packaging, and development groups.

Responsibilities include managing labeling approvals, ensuring Prop 65 compliance, maintaining FDA submissions, and refining SOPs to improve process efficiency and quality across private label and commercial products.