Remote CMC Regulatory Scientist III – Strategy & Submissions

Cardinal Health; United States; Remote; USD 95,000 - 136,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

Paid time off

Job summary

Cardinal Health, headquartered in Dublin, Ohio, seeks a Scientist III CMC to lead development and regulatory strategy for pre- and post-approval activities in a global context. You will author, review, and coordinate CMC documentation and ensure compliance with health authorities during manufacturing, testing, and auditing processes.

The role requires advanced regulatory affairs experience, strong attention to detail, and the ability to manage lifecycle submissions across Rx and non-Rx products

Qualifications

• Advanced CMC regulatory affairs experience in support of pharmaceutical product development and quality assurance is required.
• Proficiency with Health Authority regulations (FDA, EMA, HealthCanada, etc.) Module 2 and Module 3 authoring experience is a plus.

Responsibilities

• Develop regulatory strategy and execution plans for pre-approval, post-approval changes, and lifecycle management activities.
• Author, review, and approve high-quality regulatory documents for submissions and responses to health authority inquiries.
• Collaborate with cross-functional teams (CMC, Quality, Clinical, Supply Chain) to align on regulatory strategy.

Job description

Cardinal Health, headquartered in Dublin, Ohio, seeks a Scientist III CMC to lead development and regulatory strategy for pre- and post-approval activities in a global context. You will author, review, and coordinate CMC documentation and ensure compliance with health authorities during manufacturing, testing, and auditing processes.

The role requires advanced regulatory affairs experience, strong attention to detail, and the ability to manage lifecycle submissions across Rx and non-Rx products