Associate Director of Regulatory Affairs

Job Summary

Supporting the development and execution of clinical regulatory strategies, the remote Associate Director of Regulatory Affairs will manage regulatory submissions, provide guidance to cross-functional teams, and ensure compliance with applicable regulations and internal standards.

Key responsibilities

• Support the development and execution of clinical regulatory strategies and plans for assigned programs
• Plan, prepare, and manage Investigational New Drug (IND) applications and other regulatory submissions, ensuring accuracy and timely delivery
• Provide regulatory guidance and support for health authority interactions and cross-functional development teams

Required qualifications

• Bachelor's degree in life sciences with 10 years of experience in the biopharmaceutical industry, including 8 years in regulatory affairs
• Demonstrated experience preparing and managing INDs and supporting regulatory submissions
• Experience supporting health authority interactions and cross-functional development teams
• Working knowledge of regulatory requirements and processes in major markets (U.S. and/or EU)
• Ability to work effectively in a fast-paced, matrixed, and global environment