A visionary leader in Regulatory Chemistry, Manufacturing, and Controls (CMC) strategy, dedicated to transform innovative therapeutic concepts into life-changing treatments. My strategic regulatory acumen ensures seamless global approval and lifecycle management of drug products, driving advancements in healthcare.
With a proven track record of navigating complex regulatory landscapes, I excel in developing and executing robust regulatory strategies that align with overarching program goals. My collaborative approach with cross-functional teams ensures that regulatory pathways are clear, efficient, and successful.
Strategic Leadership: Establishing regulatory strategies for CMC submissions, including clinical trials, marketing applications, and product lifecycle management, ensuring timely and successful approvals.
End-to-end regulatory expertise spanning strategy, CMC, nonclinical development, global submissions (IND, CTA, NDA, BLA, MAA), GMP and quality, biologics, biosimilars, cell and gene therapies, advanced therapeutics, medical devices, generics, regulatory publishing, analytical testing, ADME/DMPK, bioequivalence, and global regulatory consulting.
