Senior Regulatory Affairs Manager – Remote

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

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Job summary

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to support regulatory submissions and provide strategic regulatory guidance for pharmaceutical, biologic, and device development from discovery through post-approval maintenance.

You will coordinate with cross-functional teams, manage communications with health authorities, and contribute to regulatory filing routes (e.g., PAS, CBE, AR in the US).

Qualifications

• 7+ years of regulatory affairs hands-on experience in the pharmaceutical industry, including eCTD filings, regulatory strategy, risk management and change control.
• Bachelor's degree or equivalent in scientific or regulatory field; advanced degree desirable.
• Direct interface with Health Authorities via various modes (in person, video, emails).
• Strong knowledge of regulatory/cGMP requirements (21 CFR parts) and experience with radiopharmaceuticals is a plus.

Responsibilities

• Authorship or review of eCTDs for US and international health authorities.
• Support regulatory strategy for drug development.
• Ensure compliance with conditions of approval for NDAs, ANDAs, MAAs, and DMFs.

Skills

Regulatory strategy

eCTD submissions

Cross-functional collaboration

Regulatory submissions

Education

Bachelor's degree in life sciences

Tools

Microsoft Office

Job description

Cardinal Health, Inc. is seeking an experienced Regulatory Affairs professional to support regulatory submissions and provide strategic regulatory guidance for pharmaceutical, biologic, and device development from discovery through post-approval maintenance.

You will coordinate with cross-functional teams, manage communications with health authorities, and contribute to regulatory filing routes (e.g., PAS, CBE, AR in the US).