Compassionate Use Program Lead

Job Summary

A company is looking for an Associate Director, Compassionate Use/Expanded Access Program Lead.

Key Responsibilities:

• Design, implement, and manage compassionate use and expanded access strategies for products in compliance with regulatory requirements
• Coordinate cross-functional efforts to ensure timely decision-making and effective communication with external stakeholders
• Prepare and submit required documentation to regulatory agencies and maintain oversight of compliance activities

Qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field (Advanced degree preferred)
• Minimum 5 years of experience in the pharmaceutical or biotechnology industry with a focus on expanded access programs
• Strong understanding of global regulatory frameworks governing compassionate use and expanded access
• Proven experience managing complex projects, timelines, and budgets
• Proficiency with electronic data management systems and regulatory submission platforms