Subhan Mian brings years of expertise in research, project management, scientific writing, and regulatory affairs, specializing in the development of pharmaceuticals and biologics across diverse therapeutic areas. He has provided strategic leadership in both early-phase and late-stage drug development, successfully managing numerous INDs and NDAs. Subhan excels in guiding cross-functional teams with his deep knowledge in strategic planning, regulatory affairs, and medical writing, ensuring projects align with regulatory requirements from early to late stages of development. His experience spans therapeutic areas such as oncology, immunology, neuroscience, osteoarthritis, and rare diseases.
Before joining Halloran, Subhan held a leadership role in regulatory affairs at Bristol Myers Squibb. In this capacity, he chaired the regulatory affairs team responsible for Diversity and Inclusion in Clinical Trials and contributed to multiple workstreams aimed at navigating the evolving FDA guidelines in this domain. He managed several IND applications and maintenance projects, served as the primary liaison between the Sponsor and FDA Regulatory Project Managers for critical INDs, and played a key role in preparing for various FDA meetings (Types B, C, and D). Prior to this, Subhan worked as a regulatory affairs consultant at Syneos Health, where he supported over five consistent clients in overcoming early-phase drug development challenges. He has also held positions at several other BioPharma companies, including Biogen (Medical Writer), Celgene (Regulatory Affairs Manager), and Jiangsu Hengrui (Senior Manager). He has worked across various stages of drug development. His roles have involved facilitating cross-functional collaboration, maintaining INDs, managing alliances and partnerships, attending advisory board meetings, submitting key regulatory strategy deliverables, liaising with FDA project managers, and providing critical insights to senior stakeholders.
Earlier in his career, Subhan was deeply engaged in research, working as a medical writer and researcher at prestigious research institutions during his academic journey. As he advanced throughout his career, he became more immersed in regulatory affairs strategy.
University of North Carolina Eshelman School of Pharmacy, Doctor of Pharmacy (PharmD)
University of North Carolina at Chapel Hill, Bachelors of Science in Biology
Eli Lilly Drug Development Consulting Certification