Scientist I - CMC

at Cardinal Health in Montpelier, Vermont, 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 I - CMC What Chemistry, Manufacturing and Controls contributes to Cardinal Health The Scientist I - CMC supports regulatory activities for pre-approval, post-approval changes, and lifecycle management across client Rx and non-Rx products. Working as a consultant, this role assists in the preparation, review, and coordination of regulatory documentation, while ensuring alignment with applicable regulatory requirements and client expectations. The individual will collaborate closely with cross-functional teams and contribute to the timely delivery of high-quality regulatory submission content. Location Remote Responsibilities + Support the development, authoring, and compilation of regulatory documentation related to post-approval changes and lifecycle management activities. + Assist as an authoring strategist by organizing and maintaining submission-ready documents in accordance with US FDA and global regulatory requirements ( EMA , NMPA , ANVISA , PMDA , HC, TGA , etc). + Collaborate with cross-functional teams (e.g., CMC , Quality, Manufacturing, and Supply) to gather and verify required information for regulatory submissions. + Ensure documentation consistency, accuracy, and compliance with internal standards and client expectations. + Track and manage document timelines and deliverables to support regulatory milestones. + Maintain clear and proactive communication with client stakeholders while operating in a contractor capacity. + Ensures an established level of billable hours per fiscal year

Qualifications:

+ Bachelor's degree in related field, or equivalent work experience (Pharma QA, QC, Analytical Development), preferred + Familiarity with core CMC concepts (e.g., manufactur To view full details and how to apply, please login or create a Job Seeker account