Milford, MA – Prestige Scientific is excited to announce the successfully completed search for a Vice President of Regulatory Affairs with our partner, a biotechnology company focused on developing biologics for inflammatory and immune conditions with high unmet need.
The candidate hired for this role is a highly experienced regulatory affairs professional with over 15 years in the biopharmaceutical industry, bringing deep expertise in global regulatory strategy, submissions, and Health Authority interactions across the U.S., Canada, EU, and China. They have successfully led regulatory teams and managed complex portfolios, including rare and ultra-rare disease programs in immunology. Their work has resulted in multiple Fast Track designations and the submission of both BLAs and NDAs.
They have played a strategic role in shaping regulatory pathways to align with clinical and commercial goals, presenting regularly to executive leadership. Their experience spans pediatric program development, regulatory engagements with EMA and FDA, and leading submission strategies for major filings such as sBLAs, MAAs, and INDs. They have a strong track record of cross-functional leadership and mentoring, with a history of driving regulatory success across various therapeutic areas including immunology, oncology, and rare diseases.
Prestige presented 7 highly qualified individuals for this role, the hired candidate was presented 1 days from the start of the search, and the search was completed in 15 days. Congratulations to our 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.