Director or Senior Director, Regulatory Affairs

Role: Senior Manager, Regulatory Affairs at a clinical-stage biotech focused on targeted protein degradation (TPD) therapeutics, leading regulatory activities across multiple programs. Responsibilities: independently manage regulatory submissions (INDs, CTAs, amendments), serve as regulatory leader on cross-functional teams, oversee CRO collaborations, draft designation requests (e.g., Orphan, Fast Track), and support agency interactions including FDA meetings. Evaluate regulatory strategies based on guidance, precedent, and competitive landscape, contributing to development planning and regulatory compliance. Requirements: 5–7 years in drug regulatory affairs with proven submission oversight, strong knowledge of US and global (EU) regulatory processes, excellent communication skills, and ability to operate autonomously in a fast-paced environment. Preferred: familiarity with EU CTIS, experience with expedited development programs, and understanding of therapeutic areas related to immunological diseases. High-Value: biotech (targeted protein degradation), regulatory submissions (INDs, CTAs), engagement with FDA and international agencies, cross-functional leadership, strategic regulatory planning. Work Setup: Not specified.