Senior Regulatory Affairs Lead – eCTD Submissions

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

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Short‑ and long‑term disability

Work‑Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs and Product Development professional in the United States to lead eCTD submissions, shape regulatory strategy, and ensure compliance across NDA, ANDA, MAA and DMF programs.

You will interact with Health Authorities, oversee risk management, and collaborate with manufacturing and QA teams through product life cycles. Travel up to 10% may be required.

Qualifications

• 7+ years of regulatory affairs experience in pharma (drug/biologic).
• Experience drafting and reviewing eCTD filings (INDs, NDAs, ANDAs, MAAs, DMFs).
• Strong regulatory knowledge including 21 CFR parts and cGMP requirements.
• Experience with European drug applications (NA, MRP, DP, CP) preferred.
• Regulatory certifications preferred.
• Excellent written and verbal communication skills.

Responsibilities

• Authorship/review of eCTDs for US and international Health Authorities.
• Support regulatory strategy for drug development.
• Ensure compliance with conditions of approval for NDAs/ANDAs/MAAs/DMFs.
• Lead risk management reviews and change control processes.
• Provide regulatory guidance for manufacturing sites (CMOs, labs).
• Communicate with regulatory agencies and participate in inspections.

Skills

Regulatory affairs

eCTD filings

Regulatory strategy

Risk management

cGMP knowledge

Health Authority interface

Education

Bachelor's degree

Advanced degree desirable

Tools

MS Office

Job description

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs and Product Development professional in the United States to lead eCTD submissions, shape regulatory strategy, and ensure compliance across NDA, ANDA, MAA and DMF programs.

You will interact with Health Authorities, oversee risk management, and collaborate with manufacturing and QA teams through product life cycles. Travel up to 10% may be required.