Sr Manager, Regulatory Affairs

Role: Regulatory Affairs Lead responsible for developing and executing regulatory strategies for cancer therapies, including cell and gene therapies. Primary objectives include managing regulatory submissions, ensuring compliance with global guidelines, and serving as the US Regulatory Lead in cross-functional teams. Responsibilities encompass preparing and reviewing regulatory documents, interacting with authorities like FDA and EMA, assessing regulatory risks, and mentoring team members. The role also involves monitoring regulatory trends, guiding development teams on regulatory pathways, and supporting policy initiatives. Qualifications: BA/BS with 8+ years or MA/MS/MBA with 6+ years of relevant experience; experience leading regulatory submissions, with knowledge of global regulations and biologics or cell/gene therapy development preferred. Additional qualifications include knowledge of late-stage investigational drugs, marketed products, and strong cross-functional collaboration skills. High-Value: Focus on innovative cancer immunotherapies (CAR T-cell, TCR therapies), spanning preclinical to late-stage development, with regulatory oversight for IND, CTA, BLA, MAA filings. The position offers a flexible work policy with onsite and remote options, located in Santa Monica through 2026 with planned relocation in 2027, and may also be based in Foster City or Parsippany. Travel requirements are not specified.