Senior Regulatory Affairs Lead - Submissions & Strategy

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

Benefits dieser Stelle

Medical coverage

Dental coverage

Vision coverage

401k plan

HSA

PTO

MyFlexPay

Zusammenfassung

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs and Product Development professional to lead regulatory submissions and strategic planning for drug, biologic, and device development from discovery through post-approval.

You will author and review eCTDs, coordinate with Health Authorities, and guide cross-functional teams on regulatory strategy, risk management, and change control throughout the product lifecycle. Travel up to 10% may be required.

Qualifikationen

• 7+ years in regulatory affairs for pharma/biologic with eCTD filings.
• Bachelor’s degree in scientific or regulatory field; advanced degree desirable.
• Direct interface with Health Authorities via multiple modes.
• Knowledge of 21 CFR Part 11, 210, 211, 212, 314 and related guidance.

Aufgaben

• Authorship/review of eCTDs for US and international filings.
• Support regulatory strategy for drug development.
• Ensure compliance with NDA/ANDA/MAA/DMF conditions.
• Lead risk management reviews across product lifecycles.
• Engage with regulatory agencies and participate in inspections.
• Provide RA input to cross-functional teams and vendor meetings.

Kenntnisse

Regulatory affairs

eCTD filings

Regulatory strategy

Risk management

Communication with regulators

Cross-functional teams

Change control

GMP/regulatory compliance

Ausbildung

Bachelor's degree

Advanced degree desirable

Tools

Microsoft Office

Jobbeschreibung

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs and Product Development professional to lead regulatory submissions and strategic planning for drug, biologic, and device development from discovery through post-approval.

You will author and review eCTDs, coordinate with Health Authorities, and guide cross-functional teams on regulatory strategy, risk management, and change control throughout the product lifecycle. Travel up to 10% may be required.