Scientist III - CMC

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. 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. Qualifications 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, Health Canada, 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. What is expected of you and others at this level 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. Salary and Bonus Anticipated salary range: $94,900 – $135,600. Bonus eligible: No. Benefits Medical, dental, and vision coverage. Paid time off plan. Health Savings Account (HSA). 401(k) savings plan. Access to wages before pay day with myFlexPay. Flexible Spending Accounts (FSAs). Short- and long-term disability coverage. Work-Life resources. Paid parental leave. Healthy lifestyle programs. EEO Statement Candidates who are back‑to‑work, people with disabilities, without a college degree, and Veterans are encouraged to apply. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law. #J-18808-Ljbffr Healthcare Distributors Association