Hiring: Director, Global Regulatory Affairs (GRL) Company: Daiichi Sankyo Location: Basking Ridge, NJ Job Posted Time: 2026-09-10 14:01:08 Target Skills & Keywords : C, R About the job Experience: •5 years of experience in a Strategy role within Regulatory Affairs Required Skills: •Manages, directs, and drives the strategy for all regulatory activities associated with the registration and support of new and approved drug products. •Lead and oversee ensuring aligned global regulatory strategy is endorsed by the Global Project Team and governance bodies. •Serves as the primary point of contact with Alliance Partners Joint-regulatory teams and Joint-GPT. •Keeps current with latest Health Authority guidelines and provides regulatory advice to members within Regulatory, and other departments within the Company. •Communicates with outside consultants (i.e. CROs, external partners) as needed. Qualifications: •(from an accredited college or university) •Bachelor's Degree preferably in a scientific discipline required •Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD, JD) preferred •Broad and deep scientific and regulatory expertise in early- and late-stage development across modalities and therapeutic areas with focus on oncology •Drug Discovery and Development knowledge across the R&D continuum •7 or more years of relevant pharmaceutical experience including 5 years of experience in a Strategy role within Regulatory Affairs •Hands on NDA/BLA submission experience in a major geographical region, including the US •Demonstrated experience in global Health Authority negotiations •Manages complexity of regulatory strategy across regions and has the knowledge to provide regulatory guidance based on understanding of global regulations •Communicates and collaborates effectively and deals well with ambiguity Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!