Vice President of Regulatory Affairs

Job Summary

A company is looking for a Vice President, CMC Regulatory Affairs.

Key Responsibilities

• Lead the development and implementation of CMC regulatory strategy for global development programs and market applications
• Ensure effective execution of CMC regulatory strategies and high-quality submission documents
• Build and manage relationships with internal and external stakeholders while staying current with regulatory requirements

Required Qualifications, Training, and Education

• Bachelor's degree in life sciences required
• 20+ years of experience in the pharmaceutical/biopharmaceutical industry, with 15+ years in Regulatory Affairs CMC
• Proven track record of successful submissions to FDA and other health authorities
• Extensive regulatory management experience and ability to develop innovative regulatory solutions
• Experience in biologics drug development and commercial lifecycle