Associate Director, Regulatory Affairs
Core
Define and execute global regulatory strategies for a clinical-stage biopharmaceutical company developing alpha-helical peptide medicines for oncology and rare diseases.
Role type
Associate Director, Regulatory Affairs (Strategy & Operations)
Builds
Regulatory submissions (INDs, NDAs/BLAs, orphan drug applications) for Helicon-based peptide therapeutics
Domain
Biopharmaceuticals / Oncology / Rare Disease
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory strategy, FDA submission experience (NDA/BLA), oncology drug development, vendor/CRO oversight, regulatory intelligence, SOP development, cross-functional leadership
Preferred skills
Advanced degree (MS, PhD, PharmD), global regulatory experience, AI tool proficiency
Technologies
None stated
Responsibilities
Contribute to global regulatory strategy definition and execution; support end-to-end planning for INDs, NDAs/BLAs, and orphan drug applications; serve as regulatory liaison for FDA and global health authorities; oversee regulatory consultants and vendors; maintain regulatory SOPs and monitor global regulatory trends; participate in regulatory due diligence
Seniority
Senior, hands-on IC with strategic oversight