Associate Director/Director, Regulatory Strategy

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.

The salary range for this role is $180k - $235k

nChroma Bio is an equal opportunity employer, providing equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation or genetics. In addition to federal law requirements, nChroma Bio complies with applicable state and local laws governing nondiscrimination in employment.

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.

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