CMC Regulatory Scientist III – Remote

Cardinal Health; Dublin (OH); Hybrid; USD 95,000 - 136,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid time off

401k

HSA

Parental leave

FSA

Job summary

Cardinal Health invites a Scientist III, CMC to lead regulatory strategy, authoring and submission activities for pre- and post-approval changes, lifecycle management, and global dossiers.

You will collaborate with CMC, Quality, Clinical and Supply Chain teams, perform cGMP audits, mentor junior staff, and maintain strong client relationships while ensuring regulatory compliance across INDs/NDAs/ANDAs and global filings.

Qualifications

• Advanced CMC regulatory affairs experience in support of pharmaceutical product development and quality assurance is required.
• Knowledge and experience with cGMP regulations and ICH guidance.
• Proficiency with Health Authority regulations (FDA, EMA, HealthCanada, etc.)
• Module 2 and Module 3 authoring experience is a plus
• Experience with writing global regulatory applications in eCTD format
• MS/BS in Chemistry, Analytical Chemistry, or related life sciences
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Proficiency with Adobe Acrobat for document editing, formatting, and publishing.

Responsibilities

• Develop regulatory strategy and execution plan for pre-approval, post-approval changes, and lifecycle management activities.
• Serve as an author strategist, defining document structure, content strategy, and submission approach for complex regulatory dossiers.
• Author, review, and approve high-quality regulatory documents (e.g., supplements, variations, responses to health authority queries) ensuring scientific and regulatory rigor.
• Provide strategic input on CMC and lifecycle change assessments, including regulatory risk evaluation and submission pathways.
• Collaborate with cross-functional stakeholders (CMC, Quality, Clinical, Supply Chain) to drive alignment on regulatory strategy and ensure accurate and complete submission content.
• Act as a primary regulatory point of contact for assigned client projects, providing guidance and maintaining strong client relationships in a consultant role.
• Performs cGMP audits of active pharmaceutical ingredient and drug product manufacturers, and contract laboratories, domestically and internationally
• Mentor and provide day-to-day guidance to junior regulatory staff, supporting their technical development in regulatory strategy, authoring, and submission processes.

Skills

CMC regulatory affairs

cGMP regulations

Health Authority regs

Module 2/3 authoring

eCTD submissions

Chemistry degree

Analytical Chemistry

Life sciences

MS/BS degree

Microsoft Office

Adobe Acrobat

Regulatory strategy

Education

MS/BS in Chemistry/Analytical Chemistry

Tools

Adobe Acrobat

Microsoft Office

Job description

Cardinal Health invites a Scientist III, CMC to lead regulatory strategy, authoring and submission activities for pre- and post-approval changes, lifecycle management, and global dossiers.

You will collaborate with CMC, Quality, Clinical and Supply Chain teams, perform cGMP audits, mentor junior staff, and maintain strong client relationships while ensuring regulatory compliance across INDs/NDAs/ANDAs and global filings.