Senior Director, Regulatory Affairs – Client-Dedicated Embedded Role
Core
Senior regulatory leader embedded within a clinical-stage biotechnology company developing RNA-based therapeutics for oncology and immune-mediated diseases.
Role type
Senior Director, Regulatory Affairs (Client-Dedicated Embedded)
Builds
Global regulatory strategies, submission packages, and regulatory pathways for novel therapeutic candidates.
Domain
Biotechnology / Oncology / RNA-based therapeutics
Required skills
Global regulatory strategy, IND/CTA and BLA/MAA submissions, FDA/EMA/TGA interactions, oncology drug development, novel therapeutic modalities (RNA/gene/cell therapy), expedited pathways (Breakthrough/RMAT/Fast Track/Orphan), cross-functional leadership, vendor management, regulatory risk assessment
Preferred skills
Advanced degree (MS/PhD/MD), experience in small/mid-sized biotech, platform-based development, lifecycle management
Technologies
None stated
Responsibilities
Define and execute global regulatory strategies for clinical and preclinical assets; lead interactions with health authorities (FDA, EMA, etc.); prepare briefing packages and regulatory submissions; advise senior leadership on development strategy and risk; coordinate external vendors; support development of client regulatory capabilities.
Seniority
Senior Director, strategic leadership with hands-on execution