Senior CMC Regulatory Scientist — Remote

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

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.