Regulatory Scientist I, CMC - Remote

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

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.