Senior Quality & Regulatory Compliance Specialist

Cardinal Health; Dublin (OH); Hybrid; USD 58,000 - 77,000; Full time

Job summary

Cardinal Health in Dublin, OH is seeking a Regulatory Management professional for a hybrid role. You will oversee licensing for medical and pharmaceutical distribution, ensure compliance with state and federal laws, and partner with 3PLs to maintain licenses and prevent regulatory gaps.

Responsibilities include identifying risk, communicating findings to leadership, and coordinating with Legal and state boards to stay current on rules governing distribution of drugs and devices.

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.
• Excellent influencing skills.
• Must be able to multitask and work with competing priorities.

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.
• Report changes that affect CAH or 3PL partners to management.
• Manage the documents governing 3PL licensing requirements.
• Support management of QRA policies governing 3PL distribution.
• Interact with cross-functional business partners to assist in execution of the current Medical Distribution Quality Plan.

Skills

Verbal communication

Written communication

Interpersonal skills

Multitasking

Education

Bachelor's degree

Tools

SAP

Job description

Cardinal Health in Dublin, OH is seeking a Regulatory Management professional for a hybrid role. You will oversee licensing for medical and pharmaceutical distribution, ensure compliance with state and federal laws, and partner with 3PLs to maintain licenses and prevent regulatory gaps.

Responsibilities include identifying risk, communicating findings to leadership, and coordinating with Legal and state boards to stay current on rules governing distribution of drugs and devices.