Job Description
Location of Role
Radnor, PA, Gaithersburg, MD, Oxford, UK
Department
Regulatory Affairs
Job Overview
The Director of Regulatory Affairs will be responsible for assigned projects and all of the regulatory affairs activities by providing expertise to Immunocore’s development programs to include:
Regulatory scientific and tactical strategy development, IND development/submission /maintenance, BLA/sBLA development/submission/maintenance, agency liaison and regulatory intelligence. The role will also involve interacting with our global sites, both in-house and outsourced. Establishing a successful relationship with the FDA, along with being responsible for overseeing submissions to the EMA, MHRA, and other local Health Authorities providing an excellent opportunity to develop worldwide regulatory experience.
The ideal candidate will have experience gained in biologics and the preparation of late‑stage regulatory fillings, w...