Associate Director/Director, Regulatory Affairs-CMC

nChroma Bio is a clinical-stage genetic medicines company developing engineered epigenetic silencers to overcome the limitations of existing therapies and enable next-generation genomic medicines.

Requirements

• Lead cross-functional teams responsible for global RA-CMC submissions (IND/IMPD/CTAs) and responses to Health Authority questions.
• Provide strategic regulatory input to the Tech Ops and Quality organizations pertaining to global product development requirements
• Define and implement global RA-CMC regulatory strategy to support development and commercial objectives.
• Communicate RA-CMC strategies, risks, and plans effectively to leadership and project teams.
• Ensure regulatory strategies align with business goals and meet Health Authority requirements.
• Monitor and influence global RA-CMC environment changes; contribute to internal process and policy improvements.