Scientist III - CMC

Cardinal Health; Northern (KY); Hybrid; USD 95,000 - 136,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401k savings plan

HSA

Paid time off

FSAs

Disability coverage

Work-Life resources

Parental leave

Wellness programs

Job summary

Cardinal Health is seeking a Scientist III CMC to lead regulatory strategy and execution for pre- and post-approval changes and lifecycle management across client Rx and non-Rx programs. You will work as a senior consultant, authoring and reviewing high-impact documentation and aligning cross-functional teams for successful submissions.

In this role you will mentor junior staff, manage multiple priorities, and ensure submission-ready content in compliance with global regulatory requirements.

Qualifications

• Advanced experience in support of pharmaceutical product development, quality assurance and/or CMC regulatory affairs.
• Proactive, self-motivated, 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.

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).
• 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 submission content.
• Act as a primary regulatory point of contact for assigned client projects and mentor junior staff.

Skills

Regulatory affairs

CMC regulatory

FDA regulations

ICH guidance

Client-facing

Team mentoring

Document strategy

Cross-functional collaboration

Quality and compliance

Education

MS/BS in Chemistry, Analytical Chemistry, or related life sciences

Tools

Microsoft Office Suite

Adobe Acrobat

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

• 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, 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.

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.

Anticipated salary range: $94,900 - $135,600 Bonus eligible: No

Application window anticipated to close: 9/8/26

Benefits

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k 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

To read and review this privacy notice

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. We are a crucial link between the clinical and operational sides of healthcare, delivering end‑to‑end solutions and data‑driving insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care. With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges — now, and in the future.

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.