Franklin, MA – Prestige is excited to announce the successfully completed search for a Head of Regulatory Affairs for our partner, a leading international biopharma organization.
This critical hire is a highly experienced global regulatory affairs executive with over 25 years spanning regulatory agencies, large pharmaceutical companies, biotech, and generics. They have a strong track record of building and leading global regulatory organizations, shaping high-stakes regulatory strategy, and guiding companies through complex approvals, acquisitions, and corporate transformations. Their expertise covers a broad range of therapeutic areas, including pain, neuroscience, rare disease, allergy, and hospital-based products, and includes deep experience with FDA interactions, novel regulatory pathways such as 505(b)(2), and first-in-class or ultra-rare disease programs. They are also recognized for partnering closely with executive leadership and Boards, leading cross-functional teams, and driving regulatory strategy for both early- and late-stage development through commercialization.
This individual will lead global regulatory strategy across our partner's product pipeline, ensuring efficient registrations, compliance, and timely submissions from early development to post-approval. They will manage and mentor a team, drive cross-functional collaboration, and partner with global health authorities to align regulatory efforts with company objectives and regulatory requirements. They will also oversee regulatory documentation, budgets, and vendor relationships, while maintaining up-to-date expertise in global regulations and ensuring team compliance.
Prestige presented 8 individuals for this role, and the search was completed in 54 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.
