The Regulatory Affairs (RA) department at the Novartis Institutes for BioMedical Research (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. The fellow will spend the first year of the program in RA Early Development, which supports a wide range of General Medicine disease areas, including Autoimmunity/Transplantation/Inflammation, Cardiovascular & Metabolism, Cell & Gene Therapies, Infectious Diseases, Musculoskeletal, Neuroscience, Ophthalmology, Respiratory, as well as medical devices. The fellow will spend the second year of the program working with the RA teams that support Translational Clinical Oncology (TCO) and Companion Diagnostics (CDx).
The 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 full 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 and lead 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 amendments.
Utilize the procedures, systems, and databases that comply with requirements for electronic record-keeping.
Conduct regulatory intelligence research to inform the development strategy for a particular drug, disease, or therapeutic area.
Duration: Two Years
Start Date: Early July 2018
Please view the MCPHS University Novartis Biopharmaceutical Industry Fellowships website for more information.
In order to be considered for an interview at Midyear, the following should be submitted through the PPS Portal:
Updated Curriculum Vitae
Letter of Intent – please address the following questions:
Why are you interested in Regulatory Affairs?
Why are you interested in the NIBR Regulatory Affairs fellowship in particular?
What makes you a strong candidate?
The deadline for requesting an interview and submitting these materials is November 27, 2017.
*Early submission is recommended due to limited interview slots.
In addition to your application in PPS, please visit the MCPHS application portal to initiate your formal application http://www.mcphs.edu/pharmdfellow. For each position you request an interview for at PPS, please select it on the portal. Application materials must be received by December 20th.
Employer will assist with relocation costs.
Additional Salary Information: Fellows will receive a competitive salary and benefits package, including comprehensive health insurance.
About MCPHS University/Novartis Institutes for BioMedical Research
The Novartis Institutes for BioMedical Research (NIBR) is the global pharmaceutical research organization for Novartis. We are committed to discovering innovative medicines to treat diseases with high unmet medical need. With more than 6,000 scientists and physicians around the world, our open and entrepreneurial culture encourages collaboration as we work to push the boundaries of science to change the practice of medicine.