Scientist III, CMC

Cardinal Health; Frankfort (KY); Remote; USD 95,000 - 136,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health is seeking a Scientist III CMC to lead regulatory strategy and execution for pre-approval and post-approval changes, collaborating with CMC, Quality, Clinical and Supply Chain teams to drive compliant dossiers and successful submissions.

The role involves authoring and reviewing CMC documents for INDs/NDAs/ANDAs/BLAs, conducting regulatory risk assessments, and mentoring junior staff to ensure high-quality deliverables across global programs. Remote work options are available.

Qualifications

• Advanced CMC regulatory affairs experience in support of pharmaceutical product development and quality assurance is required.
• Knowledge and experience with cGMP regulations and ICH guidance.
• Proficiency with Health Authority regulations (FDA, EMA, HealthCanada, etc.)
• Module 2 and Module 3 authoring experience is a plus
• Experience with writing global regulatory applications in eCTD format
• MS/BS in Chemistry, Analytical Chemistry, or related life sciences
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Proficiency with Adobe Acrobat for document editing, formatting, and publishing.
• Understanding and application of scientific principles and techniques used in pharmaceutical product development
• Strong attention to detail and organizational skills.

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.
• Performs cGMP audits of active pharmaceutical ingredient and drug product manufacturers, and contract laboratories, domestically and internationally
• Perform remote quality assurance support – auditing of manufacturing production and testing records; protocols and data sets
• Authors and reviews CMC documents for INDs, NDAs, ANDAs, BLAs, Drug Master Files, and other similar global regulatory applications
• Manages assembly of global regulatory applications including extraction of pertinent CMC information from global regulatory databases
• 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.
• Maintains good client relationships
• Ensures an established level of billable hours per fiscal year

Skills

CMC regulatory affairs

FDA/EMA/HealthCanada knowledge

eCTD authoring

Regulatory dossier assembly

Cross-functional collaboration

Attention to detail

MS/BS in Chemistry

Microsoft Office

Adobe Acrobat

Regulatory consulting

Education

MS/BS in Chemistry or life sciences

Tools

Microsoft Office

Adobe Acrobat

Job description

US-Nationwide-FIELD

Full time

20188677

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.

Overview

Responsible for the development of new and improved products through initiating, designing, developing and executing research and product development projects.

Consulting with clients and future clients on pre-approval and post-approval manufacturing of Rx and non-Rx products; ensures compliance with health authority regulatory requirements and may be called upon to perform compliance and gap closure audits; interacts with the Health Authorities on all aspects of manufacturing, testing and auditing of products; providing client recommendation of manufacturer/vendor to produce product. Can propose strategies as well as author relevant parts of dossiers for Health Authority registration. Contributes to global knowledge share of information including discussions/presentations industrywide.

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.

• Performs cGMP audits of active pharmaceutical ingredient and drug product manufacturers, and contract laboratories, domestically and internationally

• Perform remote quality assurance support – auditing of manufacturing production and testing records; protocols and data sets

• Authors and reviews CMC documents for INDs, NDAs, ANDAs, BLAs, Drug Master Files, and other similar global regulatory applications

• Manages assembly of global regulatory applications including extraction of pertinent CMC information from global regulatory databases

• 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.

• Maintains good client relationships

• Ensures an established level of billable hours per fiscal year

Qualifications

• Advanced CMC regulatory affairs experience in support of pharmaceutical product development and quality assurance is required.

• Knowledge and experience with cGMP regulations and ICH guidance.

• Proficiency with Health Authority regulations (FDA, EMA, HealthCanada, etc.)

• Module 2 and Module 3 authoring experience is a plus

• Experience with writing global regulatory applications in eCTD format

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

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

• Proficiency with Adobe Acrobat for document editing, formatting, and publishing.

• Understanding and application of scientific principles and techniques used in pharmaceutical product development

• Strong attention to detail and organizational 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 receives general guidance on new projects

• Work reviewed for purpose of meeting objectives

• May act as a mentor to less experienced

Anticipated salary range: $94,900 - $135,600

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• 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

Application window anticipated to close: 10/30/26

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

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 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.

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.