Remote CMC Regulatory Scientist III

Cardinal Health; Hagåtña (GU); Remote; USD 95,000 - 136,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health, headquartered in Dublin, Ohio, is seeking a Scientist III CMC to lead regulatory strategy and dossier development for pre- and post-approval activities. Remote position with global scope, focusing on compliant submissions to Health Authorities and cross-functional collaboration.

You will author and review CMC documents, mentor junior staff, and manage global regulatory applications, including eCTD formats, while supporting lifecycle changes and risk assessments.

Qualifications

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

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
• Perform remote quality assurance support – auditing of manufacturing production and testing records; protocols and data sets
• Authors and reviews CMC documents for INDs, NDAs, ANDAs, BLAs, Drug Master Files, and other similar global regulatory applications
• Manages assembly of global regulatory applications including extraction of pertinent CMC information from global regulatory databases
• Mentor and provide day-to-day guidance to junior regulatory staff, supporting their technical development in regulatory strategy, authoring, and submission processes.
• Review, edit, and provide feedback on work produced by junior team members, ensuring accuracy, consistency, and compliance with regulatory and client standards.
• Promote best practices in document preparation, quality, and regulatory compliance across the team.
• Maintains good client relationships
• Ensures an established level of billable hours per fiscal year

Skills

CMC regulatory affairs

Regulatory strategy

Dossier authoring

Cross-functional collaboration

Regulatory audits

Education

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

Tools

Microsoft Office Suite

Adobe Acrobat

Job description

Cardinal Health, headquartered in Dublin, Ohio, is seeking a Scientist III CMC to lead regulatory strategy and dossier development for pre- and post-approval activities. Remote position with global scope, focusing on compliant submissions to Health Authorities and cross-functional collaboration.

You will author and review CMC documents, mentor junior staff, and manage global regulatory applications, including eCTD formats, while supporting lifecycle changes and risk assessments.