Scientist I - CMC

Cardinal Health; Northern (KY); Hybrid; USD 43,000 - 56,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401k plan

HSA

PTO

FSAs

Job summary

Cardinal Health, headquartered in Dublin, Ohio, seeks a Scientist I - CMC to support regulatory activities for pre- and post-approval changes and lifecycle management. You will coordinate with cross-functional teams to deliver high-quality regulatory submission content while ensuring compliance with FDA, EMA and other major authorities.

The role emphasizes remote work and contractor collaboration, with emphasis on timely deliverables, attention to detail, and strong communication with clients.

Qualifications

• Bachelor's degree in related field or equivalent work experience in Pharma QA/QC/Analytical Development.
• Strong written and verbal communication skills and attention to detail.
• Proactive, self-motivated and able to work independently in a client-facing role.
• Familiarity with cGMP and ICH guidance and experience with writing regulatory applications in eCTD format.

Responsibilities

• Support development, authoring and compilation of regulatory documentation for post-approval changes and lifecycle management.
• Organize and maintain submission-ready documents per US FDA and global regulatory requirements.
• Collaborate with cross-functional teams (CMC, Quality, Manufacturing, Supply) to gather information for submissions.
• Ensure documentation accuracy, consistency and compliance with internal standards and client expectations.
• Track timelines and deliverables to support regulatory milestones.
• Communicate clearly with client stakeholders while operating as a contractor.
• Ensure an established level of billable hours per fiscal year.

Skills

Attention to detail

Communication skills

Self-motivation

Team collaboration

Education

Bachelor's degree

Tools

Microsoft Office

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 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., manufacturing, control strategy, change management) and general awareness of post-approval variation requirements across major health authorities (e.g., FDA, EMA, NMPA, PMDA, ANVISA, TGA, Health Canada) is preferred.
• Proactive, self‑motivated, and able to work independently in a client‑facing role.
• Strong attention to detail and organizational skills.
• Effective written and verbal communication skills.
• Ability to manage multiple tasks and meet deadlines in a dynamic environment.
• Basic proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Working knowledge of 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.
• Knowledge and experience with cGMP regulations and ICH guidance.
• Experience with writing global regulatory applications in eCTD format.

What is expected of you and others at this level

Applies foundational CMC and regulatory concepts to support project deliverables with attention to quality and detail. Contributes to project activities with increasing autonomy, proactively seeking guidance when needed. Interprets and applies established procedures to address routine technical and regulatory questions. Demonstrates a strong learning mindset, building CMC and global regulatory knowledge (including post-approval lifecycle management) through hands‑on project work. Effectively manages assigned tasks and deadlines in a remote setting, showing self‑motivation and accountability. Adapts to evolving project priorities and supports multiple client needs as part of a consulting environment. Communicates clearly and collaborates with team members to ensure alignment and progress on deliverables. Supports client projects by delivering high-quality work products and developing regulatory acumen over time.

Anticipated hourly range: $31.50 - $40.41 per hour

Bonus eligible: No

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

Application window anticipated to close: 9/8/26

The hourly 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.

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.

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.