Franklin, MA – Prestige is excited to announce the successfully completed search for an Associate Director of Regulatory Writing for our partner, a leading international biopharma organization.
The individual hired for this role brings over a decade of professional writing experience, including more than five years in biotech focused on regulatory-facing clinical documentation supporting IND through late-stage development programs in immunology, oncology, and pulmonary disease. With an MS in Biological Engineering and a strong foundation in immunology and immunotherapy, they excel at translating complex clinical data into clear, submission-ready narratives. They have authored and coordinated key regulatory documents, including protocols, CSRs, Investigator’s Brochures, DSURs, and IND submissions, while also helping build and scale medical writing infrastructure, processes, and cross-functional operating models in growing organizations.
This critical hire will lead the development of high-quality clinical regulatory submission documents that are clear, concise, and scientifically accurate. They will serve as the primary Regulatory Writing representative on assigned programs, driving timelines and deliverables across functional partners. The will integrate complex scientific and clinical data from multiple sources to create regulatory-ready content aligned with company standards. They will also support process optimization initiatives, and mentor junior and external writers.
Prestige presented 6 individuals for this role, the hired candidate was presented 7 days from the start of the search, and the search was completed in 37 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.
