Senior Regulatory Affairs Manager: Strategy & Submissions

Cardinal Health, Inc.; Virginia; Vor Ort; USD 125.000 - 179.000; Vollzeit

Benefits dieser Stelle

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)

Short‑ and long‑term disability

Work‑Life resources

Paid parental leave

Healthy lifestyle programs

Zusammenfassung

Cardinal Health, Inc. is seeking a senior Regulatory Affairs professional to lead eCTD submissions and regulatory strategy for drug, biologic, and device development from discovery through post-approval maintenance.

You will partner with cross-functional teams, manage interactions with Health Authorities, ensure compliance with 21 CFR parts, and mentor colleagues. Travel up to 10% is expected.

Qualifikationen

• 7+ years of hands-on regulatory affairs experience in pharma/biologics.
• Regulatory filings and eCTD management for INDs/NDAs/MAAs/DMFs.
• Experience interfacing with Health Authorities (face-to-face, telecon, email).
• Knowledge of 21 CFR parts and regulatory guidance for sterile injectables and oral capsules.
• Experience with European drug applications (NA, MRP, DP, CP) preferred.
• Strong written and verbal communication; ability to mentor others.

Aufgaben

• Authorship/review of eCTDs for US and outside-US submissions.
• Support regulatory strategy for drug development.
• Ensure compliance with NDA/AND A/MAA requirements.
• Lead risk management reviews across product life cycles; participate in change control.
• Provide regulatory input for manufacturing sites, CMOs, and labs.
• Communicate with regulatory agencies; participate in inspections and meetings.
• Represent RA in cross-functional teams and vendor meetings.

Kenntnisse

Regulatory affairs

Leadership

Regulatory strategy

Ausbildung

Bachelor's degree or equivalent (science/regulatory)

Regulatory Affairs Certification

Tools

Microsoft Office

Jobbeschreibung

Cardinal Health, Inc. is seeking a senior Regulatory Affairs professional to lead eCTD submissions and regulatory strategy for drug, biologic, and device development from discovery through post-approval maintenance.

You will partner with cross-functional teams, manage interactions with Health Authorities, ensure compliance with 21 CFR parts, and mentor colleagues. Travel up to 10% is expected.