Senior Regulatory Affairs Manager - Global Submissions & Strategy

Cardinal Health, Inc.; Kentucky; On-site; USD 125,000 - 179,000; Full time

Benefits offered by this job

Medical insurance

PTO

401k

Job summary

Cardinal Health, Inc. seeks a seasoned Regulatory Affairs and Product Development professional in the United States to lead eCTD submissions, regulatory strategy for drug development, and compliance across NDA/ANDAs/MAAs.

The role emphasizes collaboration with manufacturing, QA, and clinical teams to guide projects from discovery through post‑approval. The ideal candidate has 7+ years of experience in regulatory affairs, a scientific or regulatory degree, and experience with Health Authorities.

Qualifications

• 7+ years of regulatory affairs hands‑on experience in the pharmaceutical industry.
• Experience with eCTD filings for INDs, NDAs, ANDAs, MAAs, and DMFs.
• Regulatory strategy development and risk management.
• Strong written and verbal communication with regulators.
• Knowledge of 21 CFR Parts and regulatory guidance for sterile injectables/oral products.

Responsibilities

• Authorship/review/oversight of eCTDs for drug submissions to US and outside-US authorities.
• Support regulatory strategy for drug development.
• Ensure compliance with NDA/ANDA/MAA approval conditions.

Skills

Regulatory affairs

eCTD submissions

Regulatory strategy

Cross‑functional collaboration

Communication

Education

Bachelor's degree in scientific/regulatory field

Advanced degree desirable

Tools

MS Office

Regulatory filing software

Job description

Cardinal Health, Inc. seeks a seasoned Regulatory Affairs and Product Development professional in the United States to lead eCTD submissions, regulatory strategy for drug development, and compliance across NDA/ANDAs/MAAs.

The role emphasizes collaboration with manufacturing, QA, and clinical teams to guide projects from discovery through post‑approval. The ideal candidate has 7+ years of experience in regulatory affairs, a scientific or regulatory degree, and experience with Health Authorities.