Senior CMC Regulatory Scientist (Remote)

Cardinal Health; Pierre (SD); Remote; USD 95.000 - 136.000; Vollzeit

Benefits dieser Stelle

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)

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Zusammenfassung

Cardinal Health in the United States is seeking a Scientist III CMC to lead the regulatory strategy and lifecycle management for Rx and non-Rx products, including pre- and post-approval activities. You will interact with Health Authorities and coordinate global submissions from discovery through lifecycle changes.

The role emphasizes authoring, reviewing, and approving regulatory documents, collaborating with cross-functional teams, and mentoring junior staff in regulatory strategy and

Qualifikationen

• Advanced CMC regulatory affairs experience in pharma product development.
• Knowledge of cGMP regulations and ICH guidance.
• Proficiency with Health Authority regulations (FDA, EMA, HealthCanada).
• Module 2 and Module 3 authoring experience is a plus.
• Experience with writing global regulatory applications in eCTD format.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Proficiency with Adobe Acrobat for document editing and publishing.
• Understanding and application of scientific principles in pharmaceutical product development.
• Strong attention to detail and organizational skills.

Aufgaben

• 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 and maintaining client relationships.
• Performs cGMP audits of API and drug product manufacturers and contract laboratories, domestically and internationally.
• Perform remote quality assurance support – auditing manufacturing production and testing records; protocols and data sets.
• Authors and reviews CMC documents for INDs, NDAs, ANDAs, BLAs, and other global regulatory applications.
• Mentor and provide day-to-day guidance to junior regulatory staff.
• Review, edit, and provide feedback on work produced by junior team members, ensuring accuracy and compliance.
• Promote best practices in document preparation, quality, and regulatory compliance.
• Maintains good client relationships.
• Ensures an established level of billable hours per fiscal year.

Kenntnisse

CMC regulatory affairs

cGMP knowledge

FDA/EMA/HealthCanada regulations

eCTD authoring

Regulatory strategy

Regulatory submissions

Attention to detail

Ausbildung

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

Tools

Microsoft Office Suite

Adobe Acrobat

Jobbeschreibung

Cardinal Health in the United States is seeking a Scientist III CMC to lead the regulatory strategy and lifecycle management for Rx and non-Rx products, including pre- and post-approval activities. You will interact with Health Authorities and coordinate global submissions from discovery through lifecycle changes.

The role emphasizes authoring, reviewing, and approving regulatory documents, collaborating with cross-functional teams, and mentoring junior staff in regulatory strategy and