Regulatory Quality & Licensing Leader

Hobbsnews; Dublin, Northern (OH, KY); Hybrid; USD 58,000 - 77,000; Full time

Benefits offered by this job

Medical, dental & vision coverage

PTO

HSA

401k

MyFlexPay

FSAs

Disability coverage

Work-Life resources

Parental leave

Wellness programs

Job summary

Cardinal Health is seeking a Regulatory Management professional to oversee licensing, compliance and risk management for Medical and Pharmaceutical Distribution operations, including 3PL partners. The role ensures adherence to FDA and state regulations across distribution of drugs and devices, balancing risk with operational needs.

The hybrid Dublin-based position requires strong attention to detail, excellent communication, and the ability to coordinate with Legal, QA and cross-functional teams

Qualifications

• Bachelor's degree preferred.
• 4-6 years' experience preferred.
• Knowledge of FDA regulations (21 CFR) preferred.
• State regulations for distribution of drugs/devices preferred.
• State regulations for dispensing drugs/devices preferred.
• Distribution Operations processes preferred.
• Excellent verbal, written, SAP, and interpersonal skills required.
• Excellent influencing skills.
• Ability to multitask and manage 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 Legal department and State Government Boards to stay current on rules for distribution of drugs and devices; report changes to management.
• Manage documents governing 3PL licensing requirements.
• Support management of QRA policies governing 3PL distribution.
• Work with 3PL partner to obtain sourcing and ensure compliance at each facility.
• Manage the policy governing licensing requirements.
• Provide support for field personnel relating to Licensing, NABP accreditation, License Tracker navigation, etc.
• Identify quality and regulatory issues within current processes and provide recommendations.
• Interact with cross-functional partners to execute the Medical Distribution Quality Plan.

Skills

Verbal communication

Written communication

Interpersonal skills

Attention to detail

Multitasking

Influencing skills

Education

Bachelor's degree preferred

Tools

SAP

Job description

Cardinal Health is seeking a Regulatory Management professional to oversee licensing, compliance and risk management for Medical and Pharmaceutical Distribution operations, including 3PL partners. The role ensures adherence to FDA and state regulations across distribution of drugs and devices, balancing risk with operational needs.

The hybrid Dublin-based position requires strong attention to detail, excellent communication, and the ability to coordinate with Legal, QA and cross-functional teams