Senior Regulatory Affairs Manager — Global Submissions

Cardinal Health, Inc.; Washington (District of Columbia); On-site; USD 125,000 - 179,000; Full time

Benefits offered by this job

Medical, dental & vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Early wages access (myFlexPay)

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Wellness programs

Job summary

Cardinal Health, Inc. in Washington, DC seeks a Senior Regulatory Affairs professional to lead regulatory submissions for drugs, biologics and devices from discovery through post-approval maintenance.

The role requires 7+ years in regulatory affairs, extensive eCTD experience (INDs/NDAs/MAAs/DMFs), and strong communication skills. Occasional travel and bonus eligibility are included. You will collaborate with RA, quality, and manufacturing to align regulatory strategies.

Qualifications

• 7+ years of regulatory affairs hands-on experience in pharma/biologic industry with eCTD filings (INDs, NDAs, ANDAs, MAAs, DMFs).
• Excellent knowledge of regulatory and cGMP requirements (21 CFR parts) and regulatory guidance.
• Direct interface with Health Authorities via multiple modes.
• Prior work with European drug applications (NA, MRP, DP, CP) preferred.

Responsibilities

• Authorship/review/overseeing of eCTDs for drug submissions to US and outside-US Health Authorities.
• Support regulatory strategy for drug development.
• Ensure compliance with approval conditions for NDAs, ANDAs, MAAs, and NDSs.
• Lead risk management reviews and participate in change control and cross-functional meetings.

Skills

Regulatory affairs expertise

Communication skills

Negotiation skills

Teamwork

Travel willingness

Project management

Education

Bachelor's degree in scientific/regulatory field

Advanced degree desirable

Tools

Microsoft Office

Job description

Cardinal Health, Inc. in Washington, DC seeks a Senior Regulatory Affairs professional to lead regulatory submissions for drugs, biologics and devices from discovery through post-approval maintenance.

The role requires 7+ years in regulatory affairs, extensive eCTD experience (INDs/NDAs/MAAs/DMFs), and strong communication skills. Occasional travel and bonus eligibility are included. You will collaborate with RA, quality, and manufacturing to align regulatory strategies.