Associate Director, Regulatory Affairs

📋 Description

• Contribute to global regulatory strategies and execution with cross-functional teams.
• Support end-to-end planning and submissions for INDs, NDAs, BLAs, and orphan drug applications.
• Regulatory liaison with FDA and global health authorities; assist agency interactions.
• Prepare briefing materials and coordinate internal prep for agency meetings.
• Communicate regulatory risks, milestones, timelines, and updates to leadership and teams.
• Represent Regulatory Affairs on Project/Clinical/Study Teams and align regulatory with development

🎯 Requirements

• Bachelor’s degree in a scientific discipline; MS/PhD/ PharmD preferred.
• 7+ years in pharma/biotech with at least 4 years in Regulatory Affairs.
• Experience in oncology and multiple stages of drug development.
• Proven ability to prepare and support global regulatory submissions (FDA NDA/BLA).
• Global regulatory experience and familiarity with international pathways preferred.
• Strong communication, leadership, and cross-functional collaboration skills.

🎁 Benefits

• Base salary: $170,000–$195,000, depending on experience.
• Annual target bonus as part of compensation.
• Equity participation and long-term incentive opportunity.
• Comprehensive benefits package for health, well-being, and needs.
• Opportunity to contribute to innovative therapies addressing serious diseases.
• Collaborative, growth-minded, patient-focused culture.