Remote Associate Director of Regulatory Affairs

Job Summary

A company is looking for a Remote Associate Director Global Regulatory Affairs.

Key Responsibilities

• Lead the Regulatory Working Team and ensure execution of regulatory strategies
• Serve as the primary FDA contact for projects and manage agency meetings
• Accountable for all U.S. FDA submissions and ensure compliance across global territories

Required Qualifications

• Bachelor's degree in a scientific or related field; advanced degree preferred
• Minimum of 8 years of pharmaceutical industry experience, with at least 6 years in regulatory affairs
• Experience managing major regulatory filings and contributing to regulatory strategies
• Strong knowledge of drug development processes and FDA/international regulations
• Demonstrated leadership experience and ability to manage teams effectively