Remote Regulatory Affairs Manager (Pharma & Devices)

Cardinal Health, Inc.; Olympia (WA); Remote; USD 125.000 - 179.000; Vollzeit

Benefits dieser Stelle

Medical, dental and vision coverage

Paid time off

401k savings plan

Flexible spending accounts (FSAs)

Life/Disability coverage

Zusammenfassung

Cardinal Health, Inc. is seeking a seasoned Regulatory Affairs professional to lead eCTD submissions and regulatory strategy for drug and biologic development.

You will collaborate with RA, manufacturing, and QA teams to ensure compliant submissions and lifecycle management across US and international authorities. The role demands extensive experience with regulatory filings, risk management, and cross-functional teamwork.

Qualifikationen

• 7+ years of regulatory affairs hands-on experience in pharma (drug/biologic) industry.
• Experience in eCTD filings for INDs/NDAs/ANDAs/MAAs/DMFs and regulatory strategy.
• Knowledge of regulatory requirements (21 CFR parts) and cGMPs.

Aufgaben

• Authorship/review/oversight of eCTD creation for drug submissions to US and global authorities.
• Support regulatory strategy for drug development programs.
• Ensure compliance with NDA/ANDA/MAA/NDS conditions of approval.
• Lead risk management reviews across product lifecycles and change controls.
• Provide regulatory input to manufacturing sites, CMOs, and labs.
• Manage communications with regulatory agencies, including inspections.
• Participate in cross-functional teams with RA, manufacturing, and vendors.

Ausbildung

Bachelor's degree or equivalent in scientific or regulatory field

Regulatory Affairs Certification (RAC) preferred

Tools

Microsoft Office

Jobbeschreibung

Cardinal Health, Inc. is seeking a seasoned Regulatory Affairs professional to lead eCTD submissions and regulatory strategy for drug and biologic development.

You will collaborate with RA, manufacturing, and QA teams to ensure compliant submissions and lifecycle management across US and international authorities. The role demands extensive experience with regulatory filings, risk management, and cross-functional teamwork.