Senior Regulatory Affairs Lead – Global Submissions & Strategy

Cardinal Health, Inc.; Arizona; 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 an experienced Regulatory Affairs professional to support regulatory submissions and development strategies for drug, biologic, and radiopharmaceutical programs. You will oversee eCTD work, ensure compliance, and interact with Health Authorities.

The role requires strong written and verbal communication, collaboration with cross‑functional teams, and occasional travel up to 10%. A RA Certification is preferred, with a Bachelor’s degree in a scientific field.

Qualifikationen

• Bachelor’s degree or equivalent in scientific or regulatory field.
• Regulatory Affairs Certification preferred.
• Experience with eCTD filings for INDs/NDAs/ANDAs/MAAs/DMFs.
• Knowledge of 21 CFR Parts 11, 210, 211, 212, 314.
• Direct interface with Health Authorities.
• Excellent written and verbal communication skills.
• Proficient with Microsoft Office and regulatory documentation tools.

Aufgaben

• Authorship/review of eCTDs for US and international submissions.
• Support regulatory strategy for drug development.
• Ensure compliance with approval conditions for NDAs/ANDAs/MAAs/DMFs.
• Lead risk management reviews and change control processes.
• Advise on regulatory requirements for manufacturing sites and CMOs.
• Manage communications with regulatory agencies and inspections.
• Provide RA input into cross‑functional teams and vendor meetings.

Kenntnisse

Regulatory affairs

Excellent communication

Independent work

Team collaboration

Regulatory inspection experience

Travel up to 10%

Ausbildung

Bachelor’s degree or equivalent in scientific/regulatory field

Regulatory Affairs Certification preferred

Advanced degree desirable

Tools

Microsoft Office

Drug application software familiarity

Jobbeschreibung

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to support regulatory submissions and development strategies for drug, biologic, and radiopharmaceutical programs. You will oversee eCTD work, ensure compliance, and interact with Health Authorities.

The role requires strong written and verbal communication, collaboration with cross‑functional teams, and occasional travel up to 10%. A RA Certification is preferred, with a Bachelor’s degree in a scientific field.