Scientist III, CMC

US-Nationwide-FIELD

Full time

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a global, integrated healthcare services and products company connecting patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management. Backed by nearly 100 years of experience, with more than 50,000 employees in nearly 60 countries, Cardinal Health ranks among the top 20 on the Fortune 500.

We boast tremendous opportunities to grow and apply technical skills to meet organizational needs, empowering talented team members who mentor and uplift others, led by leaders with a focus on employee development and well-being, dedicated training programs, and a collaborative atmosphere.

We currently have a career opening for a Scientist III CMC.

** Overview*
* Responsible for the development of new and improved products through initiating, designing, developing and executing research and product development projects.

Consulting with clients and future clients on pre-approval and post-approval manufacturing of Rx and non-Rx products; ensures compliance with health authority regulatory requirements and may be called upon to perform compliance and gap closure audits; interacts with the Health Authorities on all aspects of manufacturing, testing and auditing of products; providing client recommendation of manufacturer/vendor to produce product.  Can propose strategies as well as author relevant parts of dossiers for Health Authority registration.

Contributes to global knowledge share of information including discussions/presentations industry wide.

** Location*
* Remote

** 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

** 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, Health Canada, 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.

** What is expected of you and others at this level*
* +…