Senior Regulatory Affairs Lead - Submissions & Strategy

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

Benefits dieser Stelle

Medical coverage

Dental coverage

Vision coverage

PTO

HSA

401k

MyFlexPay

FSAs

Disability insurance

Work-Life resources

Parental leave

Wellness program

Zusammenfassung

Cardinal Health, Inc. seeks an experienced Regulatory Affairs and Product Development professional to drive submissions and regulatory strategy for pharmaceutical, biologic, and device development from discovery through post‑approval maintenance.

Responsibilities include authorship/review of eCTDs for US and international Health Authorities, risk management across product lifecycles, and guiding manufacturing sites, CMOs, and laboratories on regulatory expectations.

Qualifikationen

• 7+ years of regulatory affairs experience in pharma including eCTD filings for INDs/NDAs/ANDAs/MAAs/DMFs.
• Bachelor’s degree in scientific or regulatory field; advanced degree desirable.
• Direct interface with Health Authorities via multiple modes.
• Strong knowledge of 21 CFR parts and regulatory guidance for sterile products.
• Experience with European drug applications preferred; radiopharmaceutical knowledge desirable.
• Excellent written and verbal communication; ability to author regulatory documents.
• Proficiency with Office tools and regulatory filing software.

Aufgaben

• Authorship/review/oversight of eCTDs for US and outside-US submissions.
• Support regulatory strategy for drug development.
• Ensure compliance with NDA/ANDA/MAA/DMF conditions of approval.
• Lead risk management reviews across products’ lifecycles; participate in change control.
• Provide regulatory guidance for manufacturing sites, CMOs, and labs.
• Manage communications with regulatory agencies and participate in inspections.
• Contribute RA input to cross-functional teams and vendor meetings.

Kenntnisse

Regulatory affairs

eCTD filings

Regulatory strategy

Risk management

Cross-functional teamwork

Regulatory inspections

Written communication

Project management

Ausbildung

Bachelor’s degree in science/regulatory

Advanced degree desirable

Tools

Microsoft Office

Regulatory filing software

Jobbeschreibung

Cardinal Health, Inc. seeks an experienced Regulatory Affairs and Product Development professional to drive submissions and regulatory strategy for pharmaceutical, biologic, and device development from discovery through post‑approval maintenance.

Responsibilities include authorship/review of eCTDs for US and international Health Authorities, risk management across product lifecycles, and guiding manufacturing sites, CMOs, and laboratories on regulatory expectations.