Senior Regulatory Affairs Manager (Remote)

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

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Job summary

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to support drug, biologic and device submissions from discovery through post-approval maintenance.

In this role, you will author or review eCTDs, provide regulatory strategy input, and guide manufacturing sites and CMOs. The position involves interaction with Health Authorities and cross-functional teams to ensure compliance and timely filings.

Qualifications

• 7+ years of regulatory affairs hands-on experience in the pharmaceutical (drug and/or biologic) industry required, including management and authorship of eCTD filings, regulatory strategy development, risk management, and change control participation.
• Bachelor's degree or equivalent experience in scientific or regulatory field preferred. Advance degree desirable.
• Documented direct interface with Health Authorities via multiple modes (face-to-face, T-con, and emails).
• Excellent knowledge of regulatory and cGMP requirements, including 21 CFR Part 11, Part 210, Part 211, Part 212, Part 314, and other relevant CFR parts for sterile injectable and oral products.

Responsibilities

• Authorship and/or review and oversight of eCTDs for US and outside-US Health Authorities.
• Support regulatory strategy for drug development.
• Ensure compliance with NDA/ANDA/MAA and other regulatory requirements.
• Provide regulatory input to manufacturing sites, CMOs, and contract labs.
• Manage communication with regulatory agencies, including on-site/remote meetings and inspections.
• Participate in cross-functional teams and vendor meetings as assigned.

Skills

Regulatory affairs

Regulatory strategy

Risk management

eCTD filings

Change control

Communication

Health Authority interface

Education

Bachelor's degree

Advanced degree desirable

Tools

Microsoft Office

Job description

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to support drug, biologic and device submissions from discovery through post-approval maintenance.

In this role, you will author or review eCTDs, provide regulatory strategy input, and guide manufacturing sites and CMOs. The position involves interaction with Health Authorities and cross-functional teams to ensure compliance and timely filings.