Remote Senior Regulatory Affairs Manager

Cardinal Health, Inc.; Lincoln (NE); Remote; USD 125,000 - 179,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

401k savings plan

HSA and FSAs

Job summary

Cardinal Health, Inc. is seeking a seasoned Regulatory Affairs professional to lead eCTD submissions and provide regulatory guidance across drug, biologic, and device development. You will coordinate strategies, interactions with Health Authorities, and lifecycle management.

The role requires 7+ years in regulatory affairs, strong regulatory expertise, and a proven ability to navigate complex submissions and compliance frameworks in the U.S. and abroad.

Qualifications

• 7+ years of regulatory affairs experience in pharma/biologic industries.
• Experience authoring/eCTD filings for INDs, NDAs, ANDAs, MAAs, DMFs.
• Strong knowledge of regulatory requirements and cGMPs.

Responsibilities

• Authors/reviews eCTDs for US and international health authorities.
• Supports regulatory strategy for drug development programs.
• Ensures compliance with approval conditions for NDAs/ANDAs/MAAs.

Skills

Regulatory affairs

eCTD submissions

FDA interactions

Regulatory strategy

Education

Bachelor's degree

Job description

Cardinal Health, Inc. is seeking a seasoned Regulatory Affairs professional to lead eCTD submissions and provide regulatory guidance across drug, biologic, and device development. You will coordinate strategies, interactions with Health Authorities, and lifecycle management.

The role requires 7+ years in regulatory affairs, strong regulatory expertise, and a proven ability to navigate complex submissions and compliance frameworks in the U.S. and abroad.