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.
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 CTD format highly preferred
Basic proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Working knowledge of Adobe Acrobat for document editing, formatting, and publishing.
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.
Team-oriented mindset with the ability to collaborate across functions.
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: 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: 8/1/26 if interested in opportunity, please submit application as soon as possible.
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.
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