Janet Rose Rea is a distinguished regulatory and quality industry leader with a wealth of experience and success in strategy development and implementation for biologics, biosimilars, pharmaceuticals, and IVD. Msph. Rea has a solid background in product development planning assessment, regulatory and quality systems intelligence, gap analysis, and post-commercialization strategy development for domestic and international markets. She has a deep understanding of regulatory compliance needs, and her expertise covers both domestic and international regulatory strategy assessments, submission preparation/review, meeting preparation and representation, REMS, pharmacovigilance, 483/Warning Letter response, Orphan Drug/Fast-Track, pre-IND/IND, CTA, BLA, NDA, MAA among others. Msph. Rea is also skilled in integrated GXP quality systems, gap analyses, risk assessments, inspections preparation, training, comparability protocols, CAPA and deviations, audits, quality agreements, complaint handling, and phase-appropriate compliance strategies. She has a proven track record of developing project management, workflow design, and personnel development. Msph. Rea's technical expertise cuts across Biologics, Drugs, IVDs, Devices, and Drug delivery with her focus being Oncology, Viral Diseases, Genetic Rare Diseases, TNF-mediated diseases, Cardiology, Rare genetic diseases, and Pain.