Associate Director/Director, Regulatory Affairs-CMC

nChroma Bio • Boston, MA

9d

About The Position

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.

Requirements

• Experience in gene therapy and/or RNA therapeutics strongly preferred
• In-depth knowledge of global regulations, ICH/GMP requirements, CTD format, and CMC change management systems.
• Thorough understanding of drug development process and the pharmaceutical industry including global regulatory CMC requirements, guidance, accelerated regulatory review paths, and policy trends
• Ability to work independently in a fast-paced environment
• Ability to effectively collaborate in a dynamic, cross-functional environment to meet each program’s critical regulatory milestones
• Excellent communication skills, regulatory writing skills and willingness to share knowledge and lessons learned with strong attention to detail
• B.A. and/or M.S. 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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director