Director, Regulatory Affairs- Usona Institute - Usona Institute : Job Details

Usona Institute, a non-profit medical research organization founded in 2014, conducts and supports biochemical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines. Our focus is on alleviating depression and anxiety in people for whom current medical treatments fall short in offering relief and a better quality of life.

The Director, Quality Assurance provides strategic and operational regulatory leadership for Usona Institute's psychedelic drug development activities. The Director will guide and oversee the work required to obtain and maintain regulatory approval in the U.S. and internationally, ensuring alignment with organizational objectives and compliance with regulatory requirements. Reporting directly to senior leadership, the Director will manage a regulatory affairs team, fostering a collaborative and high-performing environment. The role demands a strong balance between strategic vision and tactical execution to meet organizational goals.

Our ideal candidate will have:

Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related discipline. Minimum of 10 years of progressive Regulatory Affairs experience in the pharmaceutical or biotechnology industry. Demonstrated experience with FDA regulatory submissions (e.g., IND, NDA) and successful agency interactions. Proven ability to lead, mentor, and develop small, high-impact teams. Demonstrated success in balancing strategic vision with tactical execution in a fast-paced, dynamic environment. Strong experience in implementing risk-based decision-making processes in regulatory contexts. Comprehensive knowledge of relevant FDA regulations, ICH guidelines, and global regulatory frameworks. Strong project management and organizational abilities, with a track record of driving results. Excellent written and verbal communication skills, including the ability to influence internal and external stakeholders.12+ years of relevant hands-on experience in GxP, QA leadership positions in the Biotech and/or pharmaceutical industry.

Only applications received through our website will be considered.

Additional information about Usona can be found at www.usonainstitute.org.

Diversity is important at Usona. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.