Regulatory CMC Strategist

Job Summary

A company is looking for a Regulatory CMC Strategist.

Key Responsibilities

• Define and implement global CMC regulatory strategies for product development and lifecycle activities
• Provide strategic guidance to regulatory and manufacturing teams for compliance with global regulatory requirements
• Manage high-quality regulatory CMC documentation and ensure timely submissions to regulatory authorities

Required Qualifications

• Bachelor's or advanced degree in a relevant scientific or regulatory discipline
• 5-8 years of experience in regulatory strategy within the pharmaceutical or CRO industry
• In-depth knowledge of global regulatory requirements for drug development and submissions
• Strong analytical and strategic thinking skills
• Ability to navigate complex regulatory scenarios