Associate Director Regulatory Affairs

Job Summary

A company is looking for an Associate Director Regulatory Affairs, CMC Integrated Biologics.

Key Responsibilities:

• Provide expert mentorship on CMC regulatory filing strategies for customer submissions
• Support the drafting and review of customer regulatory submissions as needed
• Contribute to the continuous improvement of regulatory processes and implement initiatives

Required Qualifications:

• Bachelor's Degree required, Master's Degree preferred
• 10+ years of related experience in regulatory affairs
• Proven experience in regulatory submissions and strategy implementation
• Strong ability to collaborate and maintain professional relationships
• Outstanding knowledge of industry regulations and trends