Associate Director, Regulatory CMC
Core
Planning, preparation, and execution of Chemistry, Manufacturing, and Controls (CMC) regulatory activities for investigational and commercial small molecule and antisense oligonucleotide (ASO) products.
Role type
Associate Director, Regulatory CMC
Builds
Regulatory submissions (INDs, IMPDs, NDAs, BLAs) and post-approval supplements for small molecule and ASO programs
Domain
Biopharmaceuticals / Regulatory Affairs / CMC
Required skills
CMC regulatory strategy, IND/BLA/NDA authoring, health authority interaction, vendor management, post-approval change management, comparability assessments, small molecule expertise, ASO expertise
Preferred skills
Antisense oligonucleotide (ASO) experience, leadership of complex CMC activities
Technologies
AI tools, digital technologies for document preparation and data analysis
Responsibilities
Support development and execution of CMC regulatory strategies; Author, compile, and review CMC sections of regulatory submissions; Coordinate CMC content development with cross-functional teams; Support health authority interactions; Maintain regulatory compliance for CMC activities; Assist with post-approval change management and technology transfers; Manage external consultants, CMOs, CROs, and regulatory vendors (via careerplan.io/jobs/5399467008-associate-director-regulatory-cmc-at-praxisprecisionmedicines)
Seniority
Senior, hands-on IC with leadership responsibilities