Associate Manager, Regulatory Affairs

Job Summary

A company is looking for an Associate Manager, Regulatory Affairs.

Key Responsibilities

• Plan and manage regulatory activities for assigned projects, ensuring compliance with regulatory requirements
• Develop and implement strategies for timely approvals of regulatory submissions
• Prepare, review, and submit regulatory dossiers, including INDs, BLAs/NDAs, and annual reports

Required Qualifications

• BA/BS in Health Science preferred
• 4+ years of experience in the pharmaceutical industry
• Experience with regulatory submissions and compliance
• Knowledge of regulatory strategies and tactics
• Familiarity with regulatory documentation and archives