Senior CMC Regulatory Scientist – Remote

Cardinal Health; Augusta (ME); Remote; USD 95,000 - 136,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health is seeking a Scientist III CMC to lead regulatory strategy and dossier development for pre- and post-approval activities, ensuring FDA/ICH compliance.

Remote work from the United States is supported. The role collaborates with cross-functional teams to author and review CMC documents, manage global regulatory submissions, and mentor junior staff.

You will contribute to lifecycle management, perform audits, and interact with health authorities to support registrations worldwide.

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).
• 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, providing guidance.

Skills

CMC regulatory affairs

Regulatory strategy

Regulatory authoring

FDA/ICH knowledge

eCTD experience

Education

MS/BS in Chemistry

Tools

Microsoft Office

Adobe Acrobat

Job description

Cardinal Health is seeking a Scientist III CMC to lead regulatory strategy and dossier development for pre- and post-approval activities, ensuring FDA/ICH compliance.

Remote work from the United States is supported. The role collaborates with cross-functional teams to author and review CMC documents, manage global regulatory submissions, and mentor junior staff.

You will contribute to lifecycle management, perform audits, and interact with health authorities to support registrations worldwide.