Regulatory CMC Scientist III — Remote, Global Submissions

Cardinal Health; Frankfort (KY); 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 execution for pre-approval and post-approval changes, collaborating with CMC, Quality, Clinical and Supply Chain teams to drive compliant dossiers and successful submissions.

The role involves authoring and reviewing CMC documents for INDs/NDAs/ANDAs/BLAs, conducting regulatory risk assessments, and mentoring junior staff to ensure high-quality deliverables across global programs. Remote work options are available.

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.
• Understanding and application of scientific principles and techniques used in pharmaceutical product development
• Strong attention to detail and organizational skills.

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

FDA/EMA/HealthCanada knowledge

eCTD authoring

Regulatory dossier assembly

Cross-functional collaboration

Attention to detail

MS/BS in Chemistry

Microsoft Office

Adobe Acrobat

Regulatory consulting

Education

MS/BS in Chemistry or life sciences

Tools

Microsoft Office

Adobe Acrobat

Job description

Cardinal Health is seeking a Scientist III CMC to lead regulatory strategy and execution for pre-approval and post-approval changes, collaborating with CMC, Quality, Clinical and Supply Chain teams to drive compliant dossiers and successful submissions.

The role involves authoring and reviewing CMC documents for INDs/NDAs/ANDAs/BLAs, conducting regulatory risk assessments, and mentoring junior staff to ensure high-quality deliverables across global programs. Remote work options are available.