Hardeep has more than 14 years of experience in regulatory affairs, with extensive experience in chemistry, manufacturing, and controls (CMC) for biologics. His experience spans in-depth regulatory strategy for large molecules (biologics, vaccines, cell and gene therapies), extensive regulatory submissions experience (IND/CTAs through BLA/MAAs), as well as broad technical CMC and manufacturing experience, ranging from preclinical to post-marketing. He has led countless health authority interactions, participated in significant due diligence activities, and led large teams both in industry and at contract research organizations. In his current role at Halloran, Hardeep supports regulatory CMC strategy and technical consulting across all biologics.
Prior to joining Halloran, Hardeep was the head of global regulatory affairs at Neurogene. He led the buildout of the regulatory team and successfully developed regulatory strategies and led operations (FDA and EMA specialty designations, health authority interactions, initial IND/CTA gap analysis, and initial filings) for multiple gene therapy candidates, as well as led efforts to draft target product profiles and clinical development plans for leading indications. He also played a critical role in supporting regulatory CMC and manufacturing strategy across the entire portfolio. Prior to Neurogene, Hardeep held senior-level positions at IQVIA including the Head of the Orphan Drug Unit, Head of CMC technical and regulatory strategy consulting services, as well as Interim Director of the Cell and Gene Therapy Translating Center. Hardeep began his professional career at MedImmune/Astrazeneca and had held increasingly senior positions over the course of a decade, specifically focused on CMC and biologics development, where he led multiple biologics and CMC/product development teams and participated in filing of dozens of INDs/CTAs and multiple BLAs.
Hardeep earned a dual Bachelors of Science in Cellular Biology and Genetics from The University of Kansas and a Doctorate of Philosophy in Biochemistry and Biophysics from The University of Kansas.