Senior CMC Regulatory Scientist – Remote

Cardinal Health, Inc.; Dublin (OH); Remote; USD 95,000 - 136,000; 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 a Scientist III CMC to lead regulatory strategy for pre- and post-approval activities and to author pivotal CMC documents. You will collaborate with cross-functional teams across global manufacturing and QA to ensure robust submissions and regulatory compliance.

The role involves cGMP audits, lifecycle management, and preparation of INDs/NDAs/DMFs for global regulators. This remote position offers exposure to international health authority interactions and

Qualifications

• Advanced CMC regulatory affairs experience in pharma product development.
• Knowledge of cGMP regulations and ICH guidance.
• Proficiency with Health Authority regulations (FDA, EMA, HealthCanada).
• Experience writing global regulatory applications in eCTD format.

Responsibilities

• Develop regulatory strategy and execution plan for pre- and post-approval changes.
• Define document structure and submission approach for complex dossiers.
• Author/review high-quality CMC regulatory documents for global submissions.
• Provide input on regulatory risk assessments and submission pathways.
• Collaborate with CMC, Quality, Clinical, and Supply Chain to align strategy.

Skills

CMC regulatory affairs

cGMP knowledge

FDA/EMA/HealthCanada regs

Module 2/Module 3 authoring

eCTD submissions

Attention to detail

Education

MS/BS in Chemistry or life sciences

Tools

Microsoft Office

Adobe Acrobat

Job description

Cardinal Health, Inc. is seeking a Scientist III CMC to lead regulatory strategy for pre- and post-approval activities and to author pivotal CMC documents. You will collaborate with cross-functional teams across global manufacturing and QA to ensure robust submissions and regulatory compliance.

The role involves cGMP audits, lifecycle management, and preparation of INDs/NDAs/DMFs for global regulators. This remote position offers exposure to international health authority interactions and