Scientist III - CMC

at Cardinal Health in Boise, Idaho, United States Job Description 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 + 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 To view full details and how to apply, please login or create a Job Seeker account