Remote Regulatory Affairs Supervisor: Compliance & Labeling

Cardinal Health; Pierre (SD); A distancia; USD 80.000 - 117.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

MyFlexPay access

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Descripción de la vacante

Cardinal Health is seeking a Supervisor, Regulatory Affairs to manage regulatory programs and cross-functional collaboration across labeling, listings, and compliance. You will oversee critical workflows, ensure alignment with FDA standards, and supervise labeling and listing specialists.

The role emphasizes SOP updates, regulatory liaison, and building risk-mitigated processes within a fast-paced environment. Remote nationwide work is supported with strong cross-functional exposure.

Formación

• Bachelor’s degree in a scientific/technical field or equivalent experience.
• 4–8 years in pharmaceutical/medical device QA or Regulatory Affairs (private label preferred).
• Experience with FDA guidance, 21 CFR Part 11, USP testing preferred.

Responsabilidades

• Oversee labeling approvals and product listings for CAH Private Label brands.
• Lead QA and regulatory investigations to support market actions and deviations.
• Manage FDA submissions including CARES Act reporting and FDA certifications.

Conocimientos

Regulatory Affairs

Quality Assurance

Cross-functional liaison

FDA/CPG knowledge

Educación

Bachelor’s degree in science/engineering

Herramientas

Kallik

FACTS

Veeva Vault QMS

GUDID

eDRLS/I4I

Descripción del empleo

Cardinal Health is seeking a Supervisor, Regulatory Affairs to manage regulatory programs and cross-functional collaboration across labeling, listings, and compliance. You will oversee critical workflows, ensure alignment with FDA standards, and supervise labeling and listing specialists.

The role emphasizes SOP updates, regulatory liaison, and building risk-mitigated processes within a fast-paced environment. Remote nationwide work is supported with strong cross-functional exposure.