Remote Regulatory Affairs Supervisor: Labeling & Compliance

Cardinal Health

Providence (RI)

Remote

USD 80,000 - 117,000

Full time

10 days ago

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Benefits offered by this job

Medical, dental and vision coverage
Paid time off
Health savings account (HSA)
401k savings plan
Disability coverage
Work-Life resources
Paid parental leave

Job summary

Cardinal Health is seeking a Supervisor, Regulatory Affairs to manage regulatory programs across labeling, drug listing, and device compliance. You’ll supervise labeling/senior specialists and ensure zero-defect regulatory objectives, collaborating with QA, packaging operations, and external vendors.

The role emphasizes SOP updates, risk mitigation, and maintaining FDA submissions, with a salary range reflecting national standards. Equal opportunity employer with comprehensive benefits.

Qualifications

  • Experience: 4–8 years in pharmaceutical/medical device QA or Regulatory Affairs.
  • Bachelor’s degree in a related field or equivalent.
  • Familiarity with FDA Compliance Policy Guides, 21 CFR Part 11, USP testing.

Responsibilities

  • Oversee labeling and listing approvals for CAH Private Label brands.
  • Review and approve Master Batch Records labeling sections and re-packaging requests.
  • Review California Prop 65 assessments to ensure marketing compliance.
  • Lead cross-functional liaison to ensure SOPs and workflows are compliant.

Skills

Regulatory expertise
Cross-functional leadership
Documentation & SOPs
Quality assurance

Education

Bachelor's degree in a 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 across labeling, drug listing, and device compliance. You’ll supervise labeling/senior specialists and ensure zero-defect regulatory objectives, collaborating with QA, packaging operations, and external vendors.

The role emphasizes SOP updates, risk mitigation, and maintaining FDA submissions, with a salary range reflecting national standards. Equal opportunity employer with comprehensive benefits.

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