Remote Regulatory Affairs Supervisor – Labeling & Compliance

Cardinal Health; San Juan (PR); 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

Flexible spending accounts (FSAs)

Short- and long-term disability

Job summary

Cardinal Health seeks a Supervisor, Regulatory Affairs to lead regulatory programs across labeling and listings for pharmaceutical, medical device, and cosmetic portfolios. The role requires coordinating with QA, operations, and legal to ensure compliance and timely submissions.

You will oversee SOPs, regulatory workflows, and cross-functional initiatives, driving zero-defect quality and adherence to evolving FDA standards.

Qualifications

• 4–8 years of pharmaceutical/medical device QA or regulatory affairs experience.
• Bachelor’s degree in a related scientific field.
• Familiarity with FDA policies, 21 CFR Part 11, and USP standards.

Responsibilities

• Oversee labeling approvals and product listings.
• Lead cross-functional regulatory projects and collaborations.
• Maintain regulatory documentation and SOPs to ensure compliance.

Skills

Regulatory Affairs

Quality Assurance

Cross-functional collaboration

FDA compliance

SOP development

Education

Bachelor's degree in a related field

Tools

Kallik

Veeva Vault QMS

GUDID system

FDA submission tools

Job description

Cardinal Health seeks a Supervisor, Regulatory Affairs to lead regulatory programs across labeling and listings for pharmaceutical, medical device, and cosmetic portfolios. The role requires coordinating with QA, operations, and legal to ensure compliance and timely submissions.

You will oversee SOPs, regulatory workflows, and cross-functional initiatives, driving zero-defect quality and adherence to evolving FDA standards.