Senior Regulatory Affairs Manager - Remote

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

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

Paid time off

Job summary

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to support drug/biologic regulatory submissions and lifecycle management. You will author and review eCTDs, guide regulatory strategy, and ensure compliance with approvals across global programs.

Responsibilities include coordinating with health authorities, leading risk reviews, and representing RA in cross-functional teams. Travel up to 10% may be required.

Qualifications

• 7+ years hands-on regulatory affairs experience in pharma/biologic industry with eCTD filings.
• Bachelor's degree or equivalent in scientific/regulatory field; advanced degree desirable.
• Experience interfacing with health authorities via multiple modes (in person, telecon, email).

Responsibilities

• Authorship/review of eCTDs for US and outside-US submissions.
• Support regulatory strategy for drug development.
• Ensure compliance with NDA/ANDA/MAA/DMF conditions of approval.
• Oversee risk management reviews across product lifecycles and change control processes.
• Provide regulatory input to program teams and participate in cross-functional meetings.

Skills

Regulatory affairs

eCTD submissions

Regulatory strategy

Health Authority interface

Education

Bachelor's degree in scientific or regulatory field

Job description

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to support drug/biologic regulatory submissions and lifecycle management. You will author and review eCTDs, guide regulatory strategy, and ensure compliance with approvals across global programs.

Responsibilities include coordinating with health authorities, leading risk reviews, and representing RA in cross-functional teams. Travel up to 10% may be required.