Senior Remote Regulatory Affairs Manager

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

Benefits offered by this job

Medical, dental and vision

Paid time off

Health savings account (HSA)

401k savings plan

Paid parental leave

Work-Life resources

Flexible spending accounts (FSAs)

Job summary

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to lead eCTD submissions and regulatory strategy across US and international programs.

You will collaborate with manufacturing, QA, and project teams to ensure timely filings and compliant product lifecycle management. The role requires hands-on regulatory expertise, strong communication with health authorities, and the ability to work in a fast-paced, cross-functional environment.

Qualifications

• 7+ years of regulatory affairs hands-on experience in the pharmaceutical industry, including eCTD filings
• Bachelor's degree or equivalent in scientific/regulatory field; advanced degree desirable
• Experience interfacing with Health Authorities via multiple modes (face-to-face, T-con, emails)
• Excellent knowledge of regulatory and cGMP requirements, including 21 CFR parts and guidance documents
• Prior work with European drug applications (NA, MRP, DP, CP) preferred
• Diplomacy and negotiation skills; ability to work independently or in a team
• Occasional travel – 10% or less
• Regulatory Affairs Certification preferred

Responsibilities

• Authorship and/or review of eCTDs for US and outside-US submissions
• Support regulatory strategy for drug development
• Ensure compliance with NDA/ANDA/MAA/NDA conditions of approval
• Lead risk management reviews and change-control processes
• Provide regulatory input to manufacturing sites and CMOs
• Manage communications with regulatory agencies and inspections
• Participate in cross-functional RA teams and vendor meetings

Skills

Regulatory affairs expertise

eCTD submissions

Regulatory strategy

Risk management

Documentation & writing

Education

Bachelor's degree in a scientific/regulatory field

Advanced degree desirable

Tools

Microsoft Office

Job description

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to lead eCTD submissions and regulatory strategy across US and international programs.

You will collaborate with manufacturing, QA, and project teams to ensure timely filings and compliant product lifecycle management. The role requires hands-on regulatory expertise, strong communication with health authorities, and the ability to work in a fast-paced, cross-functional environment.