Description

The Senior Director of Regulatory Affairs will lead the company’s regulatory strategy, providing leadership and oversight for product development to support the IND and early clinical trial application and studies. This person will serve as the company’s regulatory expert, driving the preparation and submission of regulatory filings, establishing and maintaining relationships with health authorities, and ensuring adherence to evolving standards. The successful candidate will bring a deep expertise in regulatory science, a strong understanding of cell therapy and neuroscience programs, and an ability to guide a cross-functional team through preclinical development toward first-in-human studies.

Requirements

MD or PhD, or a Master’s Degree with extensive experience. A minimum of 8+ years in regulatory affairs with 12+ years in the biotech/pharma industry, including experience in leadership roles. Proven experience leading successful IND and clinical trial applications. Demonstrated success in regulatory agency interactions and meetings. Excellent verbal and written communication skills as well as interpersonal, management, and organizational skills. Thorough knowledge of US and international regulations, standards, and guidance documents. Experience in cell therapy and the neurosciences. Ability to thrive in a dynamic, collaborative, cross-functional environment. Proficient at creating and communicating a clear vision among team members. Strategic mindset with the ability to integrate scientific, clinical, and regulatory perspectives.

Senior Director – Regulatory Affairs

Description

Requirements

GABAeron