Senior Regulatory Affairs Manager — Remote

Cardinal Health, Inc.; Santa Fe (NM); 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

Flex spending accounts

Job summary

Cardinal Health, Inc. seeks an experienced Regulatory Affairs professional to lead regulatory submissions for drugs, biologics, and devices, supporting development through post-approval maintenance.

The role focuses on eCTD creation, regulatory strategy, and cross-functional collaboration across manufacturing and testing vendors. The candidate will manage communications with Health Authorities, participate in regulatory inspections, and guide sites including CMOs.

Qualifications

• 7+ years of regulatory affairs hands-on experience in the pharma industry.
• Experience with eCTD filings for INDs, NDAs, ANDAs, MAAs, DMFs.
• Knowledge of regulatory and cGMP requirements in 21 CFR parts.
• Diplomacy and negotiation skills; able to work independently or in a team.

Responsibilities

• Authorship/review/oversight of eCTD submissions for US and international health authorities.
• Support regulatory strategy for drug development.
• Ensure compliance with NDA/ANDAs/MAAs and related requirements.
• Lead risk management reviews through product lifecycles and change control processes.
• Provide regulatory input into program/project teams and cross-functional meetings.

Skills

Regulatory submissions

eCTD authoring

Regulatory strategy

Cross-functional collaboration

Education

Bachelor’s degree in scientific or regulatory field

Advanced degree desirable

Tools

Microsoft Office

Job description

Cardinal Health, Inc. seeks an experienced Regulatory Affairs professional to lead regulatory submissions for drugs, biologics, and devices, supporting development through post-approval maintenance.

The role focuses on eCTD creation, regulatory strategy, and cross-functional collaboration across manufacturing and testing vendors. The candidate will manage communications with Health Authorities, participate in regulatory inspections, and guide sites including CMOs.