Bhumika Raina

WORK HISTORY

EDUCATION

ABOUT BHUMIKA RAINA

I am a Regulatory Affairs CMC leader with 16+ years of experience driving global regulatory strategy for complex biopharmaceutical products across the United States, Europe, and international markets.My expertise spans biologics, monoclonal antibodies, vaccines, and emerging therapeutic platforms, where I partner closely with R&D, technical operations, and executive leadership to translate scientific innovation into clear, defensible regulatory pathways.Throughout my career, I have led global CMC regulatory strategy and submissions across the product lifecycle, supporting IND (Phases 1–3), BLA, NDA, ANDA, IMPD, CTA, and MAA filings in CTD/eCTD formats. My experience includes regulatory agency interactions, pre-IND strategy, lifecycle management, site transfers, IND transfers, CBE-30/PAS supplements, and labeling strategy, enabling organizations to navigate regulatory complexity while accelerating development timelines.I bring a strong focus on integrating regulatory strategy with product development, manufacturing sciences, and quality systems, ensuring regulatory decisions support both scientific innovation and scalable manufacturing.I am particularly passionate about working with biotech innovators developing next-generation therapies, including monoclonal antibodies, mRNA platforms, and advanced protein therapeutics, where regulatory strategy plays a critical role in translating breakthrough science into therapies that reach patients worldwide.My leadership philosophy centers on building proactive regulatory strategies, fostering cross-functional collaboration, and enabling organizations to move efficiently from discovery to global approvals.Open to connecting with biotech leaders, regulatory strategists, and innovators working on the next generation of biologics and advanced therapeutic platforms.