The Regulatory Affairs (RA) department at the NIBR is responsible for providing strategic regulatory guidance to advance a diverse portfolio of compounds through the early phases of clinical research, from first-in-human (FIH) Phase I trials through proof-of-concept (PoC) Phase IIa studies. RA Early Development supports programs spanning across Oncology and a wide range of General Medicine disease areas, including Autoimmunity/Transplantation/Inflammation, Cardiovascular & Metabolism, Musculoskeletal, Neuroscience, Ophthalmology, Respiratory, and Tropical Diseases. Over the course of the two-year fellowship, the fellow will gain exposure to a multitude of these disease areas, which will help him/her to build a broad, robust foundation as a regulatory professional.

Our fellow will learn to:

• Support major regulatory submissions to enable conduct of FIH and PoC clinical studies, including Investigational New Drug applications (INDs) and Clinical Trial Applications (CTAs).
• Outline early- and late-stage development regulatory strategy for projects (small molecules, biologics, cell and gene therapies) based on alignment and input from cross-functional drug development teams as well as interpretation of relevant health authority guidance documents and regulatory precedent.
• Support preparatory activities for meetings with global health authorities including pre-IND and scientific advice meetings.
• Work with teams to prepare regulatory maintenance submissions, including IND Annual Reports, Development Safety Update Reports (DSURs), and protocol and information amendments.
• Conduct regulatory intelligence research to inform the development strategy for a particular drug, disease, or therapeutic area.
• Utilize the procedures, systems, and databases that comply with requirements for electronic record-keeping.

Duration: Two Years

Start Date: Early July 2020

View the Novartis Program Brochure for more information, or visit http://www.mcphs.edu/pharmdfellow for general program information. In addition, see all of our Novartis and other MCPHS Fellowship Program offerings here.