Senior Regulatory Affairs Lead — eCTD & NDA Expert

Cardinal Health, Inc.; South Carolina; 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

MyFlexPay access

Flexible spending accounts (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 lead eCTD submissions and regulatory strategy for drug development programs in the US and internationally.

The role involves ensuring compliance with NDA/ANDA/MAA/DMF approval conditions, guiding risk management, and participating in change control across product lifecycles, while interfacing with health authorities and cross-functional teams.

Qualifications

• 7+ years of hands-on regulatory affairs experience in pharmaceutical/biologic industry with eCTD filings for INDs, NDAs, ANDAs, MAAs, and DMFs.
• Bachelor's degree or equivalent in a scientific or regulatory field; advanced degree desirable.
• Direct interface with Health Authorities via multiple modes (face-to-face, teleconference, emails).
• Excellent knowledge of regulatory and cGMP requirements including 21 CFR parts applicable to sterile injectable drug and oral capsule manufacturing.

Responsibilities

• Authorship/review of eCTDs for US and outside-US regulatory submissions.
• Support regulatory strategy for drug development.
• Ensure compliance with approval conditions for NDAs, ANDAs, MAAs, and NDSs.
• Oversee risk management reviews and change control participation across product lifecycles.

Skills

Regulatory affairs

eCTD filings

Regulatory strategy

Risk management

Change control

Regulatory inspections

Team collaboration

Education

Bachelor's degree

Regulatory Affairs Certification

Tools

Microsoft Office

Job description

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to lead eCTD submissions and regulatory strategy for drug development programs in the US and internationally.

The role involves ensuring compliance with NDA/ANDA/MAA/DMF approval conditions, guiding risk management, and participating in change control across product lifecycles, while interfacing with health authorities and cross-functional teams.