Scientist III - CMC

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.

What Chemistry, Manufacturing and Controls contributes to Cardinal Health

The Scientist III CMC is a senior-level contributor responsible for leading regulatory strategy and execution for pre-approval, post-approval changes and lifecycle management activities across client Rx and non-Rx programs. Operating in a client-facing, consultant capacity, this role provides strategic guidance on complex regulatory submissions, authors and reviews high-impact documentation, and drives alignment across cross-functional teams to ensure successful regulatory outcomes. The individual is expected to work independently, manage competing priorities, and deliver high-quality, submission-ready content aligned with global regulatory requirements, while also supporting the development of junior staff.
Location
Remote
Responsibilities

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Develop regulatory strategy and execution plan for pre-approval, post-approval changes and lifecycle management activities.

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Serve as an author strategist, defining document structure, content strategy, and submission approach for complex regulatory dossiers.

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Author, review, and approve high-quality regulatory documents (e.g., supplements, variations, responses to health authority queries) ensuring scientific and regulatory rigor.

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Provide strategic input on CMC and lifecycle change assessments, including regulatory risk evaluation and submission pathways.

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Collaborate with cross-functional stakeholders (CMC, Quality, Clinical, Supply Chain) to drive alignment on regulatory strategy and ensure accurate and complete submission content.

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Act as a primary regulatory point of contact for assigned client projects, providing guidance and maintaining strong client relationships in a consultant role.

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Lead timeline planning, tracking, and execution of regulatory deliverables to meet critical milestones.

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Perform advanced document quality control, formatting, and publishing in compliance with global regulatory standards using tools such as MS Office and Adobe Acrobat.

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Mentor and provide day-to-day guidance to junior regulatory staff, supporting their technical development in regulatory strategy, authoring, and submission processes.

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Review, edit, and provide feedback on work produced by junior team members, ensuring accuracy, consistency, and compliance with regulatory and client standards.

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Promote best practices in document preparation, quality, and regulatory compliance across the team.

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Support regulatory inspections, audits, and responses related to lifecycle management activities, as needed.

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Ensure an established level of billable hours per fiscal year

Qualifications

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Advanced experience in support of pharmaceutical product development, quality assurance and/or CMC regulatory affairs, highly preferred

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Proactive, self-motivated, and able to work independently in a client-facing role.

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Knowledge and experience with cGMP regulations and ICH guidance.

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Proficiency with Health Authority regulations (FDA, EMA, HealthCanada, etc.)

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Experience with writing global regulatory applications in CTD format

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Ability to manage multiple tasks and meet deadlines in a dynamic environment.

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Proficiency in M