Hybrid Senior Regulatory Quality Compliance Specialist

Cardinal Health, Inc.; Dublin (OH); Hybrid; USD 58,000 - 77,000; 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

Flexible spending accounts (FSAs)

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health in Dublin, OH, is seeking a Regulatory Management professional to develop and deploy policies ensuring compliant operations for Medical and Pharmaceutical Distribution across Cardinal Health facilities and 3PL partners.

The role emphasizes licensing management with state and federal regulators, risk assessment, and cross-functional collaboration to maintain regulatory programs and NABP accreditation. A hybrid on-site arrangement in Dublin is expected.

Qualifications

• Bachelor's degree preferred.
• 4–6 years’ experience preferred.
• Knowledge of FDA regulations for prescription drugs and medical devices (21 CFR) preferred.
• Knowledge of State regulations for the purchase, sale and distribution of drugs and medical devices (21 CFR) preferred.
• Knowledge of State regulations for the dispensing of drugs and medical devices (Pharmacy, Home Medical Equipment Provider) preferred.
• Distribution Operations processes (Medical and Pharmaceutical) preferred.
• Excellent verbal, written, computer, SAP, and interpersonal skills required.

Responsibilities

• Manage Medical Distribution Facility Licensing required to distribute drugs and devices.
• Manage Pharmaceutical Distribution Facility Licensing required to distribute drugs and Controlled substances.
• Manage 3PL partner facility and pharmacy licenses required to distribute drugs and devices.
• Ensures compliance with State and Federal Laws and regulations.
• Identify and Quantify Risk, communicate results effectively to management.
• Work with the Cardinal Health Legal department and State Government Boards to remain current on state and local rules and regulations for the distribution of drugs and devices.
• Manage the documents governing 3PL licensing requirements.
• Support management of QRA policies governing 3PL distribution.
• Work with the 3PL partner to obtain sourcing and ensure compliance in each facility.
• Manage the policy governing licensing requirements.
• Provide support for Medical and Pharmaceutical Distribution field personnel relating to Licensing, NABP accreditation, License Tracker navigation, etc.
• Identify quality and regulatory related issues within current processes, investigate and provide recommendations.
• Interact with cross-functional business partners (Customers, Operations, Sourcing, State Boards of Pharmacy, field QRA, etc.) to assist in execution of the current Medical Distribution Quality Plan.

Skills

Verbal communication

Written communication

Interpersonal skills

Multitasking

Prioritization

Education

Bachelor's degree

Tools

SAP

Job description

Cardinal Health in Dublin, OH, is seeking a Regulatory Management professional to develop and deploy policies ensuring compliant operations for Medical and Pharmaceutical Distribution across Cardinal Health facilities and 3PL partners.

The role emphasizes licensing management with state and federal regulators, risk assessment, and cross-functional collaboration to maintain regulatory programs and NABP accreditation. A hybrid on-site arrangement in Dublin is expected.