Franklin, MA – Prestige is excited to announce the successfully completed search for a Senior Director of Regulatory Affairs for our partner, a leading international biopharma organization.
The individual hired for this role is a seasoned regulatory affairs leader with deep expertise in global oncology development, spanning hematologic malignancies and solid tumors, and a strong track record securing international approvals across all major regulatory agencies. They have led regulatory strategy from early IND through registrational readouts and global filings, including complex immuno-oncology programs and innovative development pathways, and have extensive experience driving FDA and ex-U.S. engagements across all phases of development. Known for their command of briefing packages, health authority meetings, and expedited programs, they have successfully achieved breakthrough, fast track, orphan, and pediatric designations.
In addition to technical depth across clinical, CMC, and companion diagnostics, they are recognized for building highly collaborative, cross-functional partnerships and for mentoring and leading teams with a hands-on, development-focused leadership style. They are also an established thought leader, with a strong record of publications, presentations, and global scientific engagement in regulatory science and oncology.
Prestige presented 15 individuals for this role, the hired candidate was presented 15 days from the start of the search, and the search was completed in 65 days. Congratulations to our Regulatory search team for this successful project!
About Prestige Scientific:
Prestige Scientific is an executive search firm that advises our clients on recruiting impactful leaders. We provide our clients with a performance-based hiring system that identifies leaders with past success meeting similar corporate objectives as their own, while overcoming challenges and adhering to critical timelines. We have dedicated experts in eleven practice areas that mirror a typical biopharma company, allowing us to support our client's growth from Discovery through Commercial.
