Associate Director, Regulatory
PharmaEssentiaBoston, Massachusetts, United States
Posted April 2, 2026
185000 - 225000 USD
PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation, is a global biopharmaceutical innovator specializing in the development and delivery of new biologics for hematology, oncology, and immunology. With a focus on rare diseases and orphan drugs, the company leverages deep expertise and proven scientific principles to advance drug development. Founded in 2003, PharmaEssentia has expanded its global presence across the U.S., Japan, China, and Korea.
We are seeking an Associate Director, Regulatory to lead compliance-focused regulatory review and governance for promotional materials across media types for the Company's products within an assigned product/therapeutic area. This role will provide strategic input early in campaign concept and copy development, ensure alignment with internal policies and external standards, and manage Form FDA 2253 submissions and OPDP advisory comment requests as appropriate.
PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation, is a global biopharmaceutical innovator specializing in the development and delivery of new biologics for hematology, oncology, and immunology. With a focus on rare diseases and orphan drugs, the company leverages deep expertise and proven scientific principles to advance drug development. Founded in 2003, PharmaEssentia has expanded its global presence across the U.S., Japan, China, and Korea.
