Remote Regulatory Affairs Manager - Global Submissions Lead

Cardinal Health, Inc.; Boston (MA); Remote; 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. seeks a seasoned Regulatory Affairs professional to lead eCTD submissions for INDs, NDAs, ANDAs, MAAs and DMFs, spanning US and global health authorities.

This role drives regulatory strategy and lifecycle management across drug, biologic, and device programs. As part of Regulatory Affairs & Product Development, you will mentor colleagues, manage risk assessments, and ensure compliance with 21 CFR requirements.

Qualifications

• 7+ years of regulatory affairs hands-on experience in pharmaceutical industry including eCTD filings for INDs/NDAs/MAAs/DMFs
• Regulatory strategy development and risk management experience
• Excellent communication with Health Authorities and cross-functional teams

Responsibilities

• Authorship/review of eCTDs for US and international submissions
• Support regulatory strategy for drug development programs
• Ensure compliance with NDA/ANDAs/MAA conditions of approval
• Manage regulatory communications and inspections with agencies
• Provide RA input to program teams and cross-functional meetings

Skills

Regulatory affairs

eCTD filings

Regulatory strategy

Regulatory communications

Travel up to 10%

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

Job description

Cardinal Health, Inc. seeks a seasoned Regulatory Affairs professional to lead eCTD submissions for INDs, NDAs, ANDAs, MAAs and DMFs, spanning US and global health authorities.

This role drives regulatory strategy and lifecycle management across drug, biologic, and device programs. As part of Regulatory Affairs & Product Development, you will mentor colleagues, manage risk assessments, and ensure compliance with 21 CFR requirements.