Remote CMC Regulatory Scientist III

Cardinal Health; Salt Lake City (UT); Remote; USD 95,000 - 136,000; Full time

Benefits offered by this job

Medical, dental, and vision

Paid time off

Health savings account (HSA)

401k savings plan

Access to wages before pay day (myFlex

Flexible spending accounts (FSAs)

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health seeks a Scientist III CMC to lead regulatory strategy and authoring for pre- and post-approval activities in a remote US setting. The role focuses on developing regulatory documents, coordinating with cross-functional teams, and ensuring compliance with global health authority requirements.

The candidate will mentor junior staff, craft submissions (eCTD), and interact with clients to drive regulatory success across INDs, NDAs, and other filings.

Qualifications

• Advanced CMC regulatory affairs experience in support of pharmaceutical product development and quality assurance.
• 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.
• 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

Regulatory strategy

Regulatory documentation

Cross-functional collaboration

Regulatory compliance

FDA/ICH knowledge

Education

MS/BS in Chemistry/Life sciences

Tools

Microsoft Office Suite

Adobe Acrobat

Job description

Cardinal Health seeks a Scientist III CMC to lead regulatory strategy and authoring for pre- and post-approval activities in a remote US setting. The role focuses on developing regulatory documents, coordinating with cross-functional teams, and ensuring compliance with global health authority requirements.

The candidate will mentor junior staff, craft submissions (eCTD), and interact with clients to drive regulatory success across INDs, NDAs, and other filings.