Senior CMC Regulatory Scientist, Remote

Cardinal Health; Carson City (NV); 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

Job summary

Cardinal Health in the United States is seeking a Scientist III CMC to lead development and regulatory strategy for Rx and non-Rx products. This role focuses on pre- and post-approval activities, dossier authoring, and interacting with Health Authorities to ensure compliant submissions.

You will collaborate with CMC, Quality, Clinical and Supply Chain teams, perform audits, mentor junior staff, and contribute to global regulatory programs.

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 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 to drive alignment on regulatory strategy and ensure accurate submission content.
• Act as a primary regulatory point of contact for assigned client projects and maintain strong client relationships.

Skills

Regulatory affairs

cGMP compliance

FDA/EMA/HealthCanada knowledge

eCTD writing

Documentation discipline

Client relationship management

Education

MS/BS in Chemistry, Analytical Chemistry, or related life sciences

Tools

MS Office

Adobe Acrobat

Job description

Cardinal Health in the United States is seeking a Scientist III CMC to lead development and regulatory strategy for Rx and non-Rx products. This role focuses on pre- and post-approval activities, dossier authoring, and interacting with Health Authorities to ensure compliant submissions.

You will collaborate with CMC, Quality, Clinical and Supply Chain teams, perform audits, mentor junior staff, and contribute to global regulatory programs.