The Company is seeking an Executive Director of Regulatory Affairs to join their team. The successful candidate will be a senior leader with a strong background in developing and executing global regulatory strategies for a diverse product portfolio. This role is pivotal in driving regulatory decisions that align with clinical and commercial objectives, ensuring compliance with all relevant regulations, and ultimately accelerating the development of innovative treatments for patients with significant unmet medical needs. The Executive Director will be responsible for leading interactions with global health authorities, providing regulatory intelligence, and overseeing the preparation and submission of major regulatory filings. Applicants must have a Bachelor's degree in a relevant field, with an advanced degree preferred, and at least 12-15 years of regulatory affairs experience in the pharmaceutical, biotechnology, or medical device industry. The role requires a deep understanding of FDA regulations and guidance, as well as experience in leading BLA, NDA, or MAA submissions. Strong leadership skills are essential, as the Executive Director will be tasked with building and mentoring a high-performing regulatory affairs team. Experience in clinical regulatory strategy, including protocol design input and trial design, is also a key qualification. The ideal candidate will have a proven track record in managing complex regulatory interactions, be familiar with various therapeutic areas, and have global regulatory experience, including ex-US submissions.

Hiring Company

Ardelyx, Inc.