Senior Regulatory Affairs Strategist

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

Benefits dieser Stelle

Medical, dental and vision coverage

401k savings plan

Paid time off

Zusammenfassung

Cardinal Health, Inc. is seeking a seasoned Regulatory Affairs professional to lead regulatory submissions and strategy for drug, biologic, and device development in the US and globally.

The role emphasizes eCTD authoring/review, risk management, and cross-functional collaboration with manufacturing and quality teams. The ideal candidate has 7+ years in regulatory affairs, strong communication skills, and experience with FDA regulations and international health authorities.

Qualifikationen

• 7+ years of regulatory affairs experience in the pharmaceutical or biologics industry.
• Bachelor’s degree or equivalent in scientific or regulatory field; advanced degree desirable.
• Experience with Health Authorities and eCTD filings for INDs/NDAs/MAAs/DMFs and regulatory strategy development.

Aufgaben

• Authorship and/or review of eCTDs for US and international drug submissions.
• Support regulatory strategy for drug development.
• Ensure compliance with NDA/ANDA/MAA/NDS conditions of approval.

Kenntnisse

Regulatory affairs

eCTD filings

Regulatory strategy

Risk management

Communication skills

Cross-functional collaboration

Documentation & record keeping

Ausbildung

Bachelor’s degree in scientific or regulatory field

Advanced degree desirable

Tools

Microsoft Office

Jobbeschreibung

Cardinal Health, Inc. is seeking a seasoned Regulatory Affairs professional to lead regulatory submissions and strategy for drug, biologic, and device development in the US and globally.

The role emphasizes eCTD authoring/review, risk management, and cross-functional collaboration with manufacturing and quality teams. The ideal candidate has 7+ years in regulatory affairs, strong communication skills, and experience with FDA regulations and international health authorities.