Regulatory Affairs Associate

Job Summary

A company is looking for a Regulatory Affairs Associate II.

Key Responsibilities

• Prepare CMC regulatory submissions and manage content strategy for regulatory submissions under management supervision
• Analyze and interpret information impacting regulatory decisions and respond to global regulatory information requests
• Manage products and change control, ensuring compliance with regulations and company policies under management supervision

Required Qualifications

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering, or a related subject
• 4 years of pharmaceutical or industry-related experience
• 1-2 years in quality systems or cross-functional project management
• Experience working in a complex and matrix environment
• Relevant advanced degree and certification preferred