Senior Regulatory Affairs Lead, FDA Submissions & Strategy

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

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

MyFlexPay access

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to drive eCTD submissions for US and global health authorities.

You will support regulatory strategy across drug development, ensuring compliance with NDA/ANDA/MAA requirements and leading risk management and change control initiatives. The role requires strong communication with regulators, cross‑functional collaboration, and experience with cGMP and 21 CFR guidelines.

Qualifications

• Hands‑on regulatory affairs experience in pharma/biologic industries.
• Experience managing eCTD filings for INDs, NDAs, ANDAs, MAAs, or DMFs.
• Ability to interface with Health Authorities through multiple channels.
• Knowledge of regulatory and cGMP requirements including 21 CFR parts.
• Experience with European drug applications (NA, MRP, DP, CP) preferred.

Responsibilities

• Authorship/review of eCTDs for US and international submissions.
• Support regulatory strategy for drug development programs.
• Ensure compliance with approval conditions for NDAs/ANDAs/MAAs.
• Lead risk management reviews and change control processes.
• Provide regulatory guidance for manufacturing sites, CMOs, and labs.
• Coordinate communications with regulatory agencies and inspections.
• Contribute RA input to cross‑functional project teams.

Skills

Regulatory affairs

eCTD submissions

Regulatory strategy

Risk management

Change control

Health Authority interface

cGMP knowledge

21 CFR familiarity

Excellent communication

Education

Bachelor's degree in scientific/regulatory field

Advanced degree desirable

Tools

Microsoft Office

Job description

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to drive eCTD submissions for US and global health authorities.

You will support regulatory strategy across drug development, ensuring compliance with NDA/ANDA/MAA requirements and leading risk management and change control initiatives. The role requires strong communication with regulators, cross‑functional collaboration, and experience with cGMP and 21 CFR guidelines.