Associate Director/Director, Regulatory Strategy

nChroma Bio • Boston, MA

5d

About The Position

The Associate Director/Director, Regulatory Strategy will oversee the management, coordination and execution of regulatory activities for nChroma’s early development programs. This position supports nChroma’s regulatory efforts and partners with the nonclinical, clinical development, and clinical operations functions, as well as other regulatory team members. This role reports into the VP Regulatory Affairs.

Requirements

• Experience in gene therapy, gene editing and/or RNA therapeutics strongly preferred
• In-depth knowledge of global regulations, ICH/GMP requirements, CTD format.
• Thorough understanding of drug development process and the pharmaceutical industry including global regulatory 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

• Responsible for coordinating and driving regulatory submissions, including submission teams and timelines, for assigned programs
• Represent regulatory function on cross-functional teams
• Support US, EU, and global clinical trials including the preparation of initial INDs/CTAs and amendments, responses to agency questions, and maintenance activities.
• Support development and implementation of regulatory strategies to facilitate the progress of programs through all phases of development
• Collaborate with cross-functional teams to generate and refine the product development strategy
• Ensure regulatory strategies align with business goals and meet Health Authority requirements.
• Actively monitor regulatory policy and intelligence and disseminate information to teams; contribute to internal process and policy improvements.

What This Job Offers

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