Remote CMC Regulatory Scientist III

Cardinal Health; Bismarck (ND); Remote; USD 95,000 - 136,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

401k savings plan

Flexible spending accounts (FSAs)

Employee assistance programs

Job summary

Cardinal Health is seeking a Scientist III CMC to lead regulatory strategy for pre- and post-approval changes, and to author high-quality CMC documents for INDs, NDAs, ANDAs and global filings. This remote role collaborates with cross-functional teams to ensure regulatory excellence and alignment with Health Authority requirements.

The ideal candidate will have advanced CMC regulatory affairs experience, familiarity with ICH/good manufacturing practices, and strong authoring skills in eCTD.

Qualifications

• Advanced CMC regulatory affairs experience in pharma product development and QA.
• Familiar with FDA/EMA/Health Canada guidelines and Health Authority regs.
• Experience writing global regulatory applications in eCTD format.
• Strong attention to regulatory details and document quality.

Responsibilities

• Develop regulatory strategy and execution plans for pre- and post-approval activities.
• Define structure and approach for complex regulatory dossiers.
• Author/review/approve CMC documents ensuring scientific rigor.
• Provide input on lifecycle changes and submission pathways.
• Collaborate with cross-functional teams to align regulatory content.
• Serve as regulatory point of contact for client projects and audits.
• Perform regulatory audits of manufacturing and contract labs, domestically and internationally.
• Mentor junior staff in regulatory strategy and submissions.

Skills

Regulatory affairs (CMC)

cGMP knowledge

Health Authority regulations

Module 2 and 3 authoring

eCTD submissions

Chemistry/Analytical background

Microsoft Office

Adobe Acrobat

Regulatory strategy

Attention to detail

Education

MS/BS in Chemistry or life sciences

Tools

MS Office Suite

Adobe Acrobat

Job description

Cardinal Health is seeking a Scientist III CMC to lead regulatory strategy for pre- and post-approval changes, and to author high-quality CMC documents for INDs, NDAs, ANDAs and global filings. This remote role collaborates with cross-functional teams to ensure regulatory excellence and alignment with Health Authority requirements.

The ideal candidate will have advanced CMC regulatory affairs experience, familiarity with ICH/good manufacturing practices, and strong authoring skills in eCTD.