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.

This leadership role requires an individual to specifically have the education and experience to plan, direct, and coordinate regulatory activities to support Usona’s drug development programs. This position provides expertise to ensure compliance with federal and state regulations across all functional areas of drug development. Strong knowledge of FDA regulations and submissions is required, as well as established experience interfacing with global regulatory agencies.

Our ideal candidate will have:

• Bachelor’s degree, preferably in Regulatory Science or a health science field.
• A minimum of 15 years’ experience in the pharmaceutical industry (small molecule) or a related area. (Proven 5 years in a senior leadership role with strong management skills).
• Strong scientific or clinical research background required.
• Demonstrated knowledge of regulatory affairs, such as 21 CFR 210/211/310/312/314, FDA guidance documents, and ICH guidelines for both development projects and commercial projects, with evidence of successful submissions to FDA, EMA, MHRA, or other health authorities
• Demonstrated track record of preparing original INDs, NDAs, and amendments in compliance with applicable FDA regulations.

To apply, view a complete job description, and learn more about our company, please visit:

https://careers-usonainstitute.icims.com/jobs/3486/director%2c-regulatory-affairs%2c-pharmaceutical-products%2c-usona/job

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.

About Usona

Promega is an international bio-tech company with over 4000 high quality products that have been supporting science for over 40 years. We support scientists researching life and disease, pharma companies developing new treatments, forensic labs matching DNA from crime scenes and clinical labs running and confirming health tests - and that’s just the beginning. And yes, we have been extremely busy providing our technologies to support COVID-19 testing and research. We strive to create an open, inviting and inclusive culture – we care about you as a person, not just a team member. We embrace the principles of emotional and social intelligence – which helps our employees improve relationships, manage stress and enhance connections. Establishing and maintaining relationships is part of the foundation of our culture - teams are more like family than co-workers. Our campus speaks volumes. Headquartered in Madison, employees work in and around a campus with multiple buildings that are integrated into a natural setting with trails, ponds, woods and a restored prairie. Sustainability is important – we invest in energy efficiency and use renewable energy. Our culinary team offers top notch food to employees – including an onsite garden to supply fresh produce.

Connections working at Usona