Scientist III - CMC

Cardinal Health

2d•$94,900 - $135,600•Remote

About The Position

Cardinal Health is seeking a Scientist III CMC, 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. This client-facing, consultant 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.

Requirements

Advanced experience in support of pharmaceutical product development, quality assurance and/or CMC regulatory affairs, highly preferred
Proactive, self-motivated, and able to work independently in a client-facing role.
Knowledge and experience with cGMP regulations and ICH guidance.
Proficiency with Health Authority regulations (FDA, EMA, HealthCanada, etc.)
Experience with writing global regulatory applications in CTD format
Ability to manage multiple tasks and meet deadlines in a dynamic environment.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Proficiency with Adobe Acrobat for document editing, formatting, and publishing.
Team-oriented mindset with the ability to collaborate across functions.
Understanding and application of scientific principles and techniques used in pharmaceutical product development
MS/BS in Chemistry, Analytical Chemistry, or related life sciences
Strong attention to detail and organizational skills.
Effective written and verbal communication skills.
Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
May contribute to the development of policies and procedures
Works on complex projects of large scope
Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
Completes work independently with attention to detail
Receives general guidance on new projects
Work reviewed for purpose of meeting objectives
Mentor to less experienced
Support client projects as a consultant.
Work remotely from home office.
Adaptability and responsiveness to changing project priorities.

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.
Lead timeline planning, tracking, and execution of regulatory deliverables to meet critical milestones.
Perform advanced document quality control, formatting, and publishing in compliance with global regulatory standards using tools such as MS Office and Adobe Acrobat.
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.
Support regulatory inspections, audits, and responses related to lifecycle management activities, as needed.
Ensure an established level of billable hours per fiscal year.