Associate Director/Director, Regulatory Affairs-CMC

with at least seven years of relevant experience within the biotech or pharmaceutical industry. Minimum of 5 years in regulatory affairs in a clinical-stage and/or commercial biotechnology company.

The Associate Director/Director, RA-CMC oversees the management, coordination and execution of regulatory CMC activities for nChroma’s early development programs.  This position supports nChroma’s clinical registration and manufacturing efforts and partners with the manufacturing team, clinical operations and quality functions, and other regulatory team members. This role reports into the VP Regulatory Affairs.

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.