Associate Director / Director, Regulatory Affairs
The successful candidate will provide leadership for regulatory affairs activities related to the development and registration of the company’s drug-device combination products. The Associate...
Responsible for managing regulatory activities that support department and company projects and programs. Develops and ensures implementation of strategies and tactics for earliest possible approvals of drug filings and applications. Provides...
Support and facilitate the Regulatory Affairs (RA) activities within a highly regulated industry to ensure that Company products comply and meet regulatory requirements. This position holds significant responsibility for regulatory strategies on...
Ultragenyx Pharmaceutical Inc.
Why Join Us?
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in...
Responsible for supporting the Regulatory Affairs Department across a number of company-sponsored projects. Under supervision, has primary responsibility for assembling regulatory dossiers for review by senior regulatory affairs...
This position is responsible for planning, coordinating and preparing regulatory submissions to various government health agencies such as the U.S. FDA and foreign counterparts, with an emphasis on CMC/quality...
Facilitate preparation and completion of documentation to support electronic or paper submissions (e.g., IND, CTA, NDA) to FDA and to ex-US regulatory agencies in collaboration with team members from other functional areas and more...