Franklin, MA – Prestige Scientific is excited to announce the successfully completed search for a Chief Regulatory Officer with our partner, a biotechnology company pioneering a novel approach to treating severe diseases through their RNA-based therapies.
The individual hired for this role is a seasoned biopharma leader specializing in regulatory affairs, quality assurance, and clinical development, especially in gene and cell therapy. They've successfully built teams, streamlined operations, and led regulatory submissions across rare diseases, oncology, and regenerative medicine. Recently, they overhauled quality and compliance systems and drove a partnered Friedreich’s Ataxia program. Earlier roles include launching CRISPR-based therapies and a decade of oncology regulatory strategy, all marked by strategic vision, operational rigor, and empowered team leadership.
This critical hire will develop and execute global regulatory strategies to secure timely approvals in the U.S. and international markets while achieving competitive product labeling. They will lead regulatory interactions and negotiations with agencies such as the FDA and EMA, and ensure successful approval pathways and compliance with evolving regulatory policies. This regulatory leader will build and manage a high-performing regulatory team, provide strategic guidance on product development, lifecycle management, and business development opportunities.
Prestige presented 13 individuals for this role, the hired candidate was presented 27 days from the start of the search, and the search was completed in 79 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.
