Senior Regulatory Affairs Lead, Drug & Device Submissions

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

Benefits dieser Stelle

Medical, dental and vision

Paid time off

Health savings account

401k savings plan

Early wage access (myFlexPay)

Flexible spending accounts

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Zusammenfassung

Cardinal Health is seeking a senior Regulatory Affairs & Product Development professional to support regulatory submissions and strategy across pharmaceutical and biologic programs. You will lead eCTD compilations for US and international authorities, guide regulatory pathways, and ensure compliance with approval conditions.

The role requires strong communication, cross-functional collaboration, and occasional travel, with a salary range that reflects senior expertise and geographic

Qualifikationen

• 7+ years of regulatory affairs hands-on experience in pharma/biologic industry.
• Experience with INDs, NDAs, ANDAs, MAAs, DMFs and regulatory filings.
• Direct interface with Health Authorities via multiple modes.

Aufgaben

• Authorship/review of eCTDs for US and non-US submissions.
• Support regulatory strategy for drug development.
• Ensure compliance with approval conditions (NDAs, ANDAs, MAAs, DMFs).
• Oversee risk management reviews and change control processes.
• Provide regulatory guidance for manufacturing sites, CMOs and labs.
• Manage communication with regulatory agencies and inspections.
• Contribute RA input to cross-functional program/project teams.

Kenntnisse

Regulatory strategy

eCTD filings

Regulatory communications

Cross-functional collaboration

Mentoring

Travel up to 10%

Ausbildung

Bachelor's degree or equivalent

Advanced degree desirable

Tools

Microsoft Office

Jobbeschreibung

Cardinal Health is seeking a senior Regulatory Affairs & Product Development professional to support regulatory submissions and strategy across pharmaceutical and biologic programs. You will lead eCTD compilations for US and international authorities, guide regulatory pathways, and ensure compliance with approval conditions.

The role requires strong communication, cross-functional collaboration, and occasional travel, with a salary range that reflects senior expertise and geographic