Franklin, MA – Prestige Scientific is excited to announce the successfully completed search for an Executive Director of Regulatory Affairs with our partner, a clinical-stage biopharmaceutical company focused on developing innovative, transformational medicines.
The individual hired for this role has over 20 years of biopharma regulatory experience, with deep and broad therapeutic expertise (neurodegeneration, fibromyalgia, myasthenia gravis, peripheral ALS) and mastery of both small and large molecule regulatory pathways including biologics, siRNA, and cell therapies. Their leadership spans strategy, submissions, global markets, and therapeutic areas such as infectious disease, endocrinology, hematology, neurology, and rare diseases, including key roles in BLA and sNDA filings, as well as in building and overseeing global regulatory capabilities.
This critical hire will lead the development and execution of non-clinical and clinical regulatory strategies, including authoring and overseeing key regulatory submissions (INDs, BLAs) and leading FDA and global health authority interactions. They will serve as the global regulatory lead for assigned programs, providing cross-functional regulatory guidance and aligning internal stakeholders on strategic and operational regulatory goals. They will also build and maintain a high-performing regulatory function by mentoring staff, enhancing regulatory processes, ensuring compliance, and engaging external consultants to support program success.
Prestige presented 12 individuals for this role, the hired candidate was presented 32 days from the start of the search, and the search was completed in 48 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.
