Regulatory specialist Jobs in Madison, WI

Job Description

JOB OBJECTIVE : This role 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.

This is an onsite position located in Madison, WI. Please submit a cover letter as part of the application.

CORE DUTIES :

1. Regulatory Strategy & Leadership

• Develop and execute comprehensive regulatory strategies for psychedelic drug development programs, encompassing CMC, clinical, and nonclinical aspects.
• Serve as the primary regulatory point of contact with agencies, including the FDA, and actively contribute to interactions with global health authorities (e.g., EMA, Health Canada, MHRA).
• Implement and maintain risk-based decision frameworks to prioritize regulatory activities, ensuring alignment with organizational objectives and resource availability.
• Establish and monitor key performance indicators (KPIs) for regulatory operations, promoting continuous improvement.
• Provide proactive input to cross-functional teams (Clinical, Nonclinical, CMC, Quality, etc.) regarding U.S. and global regulatory requirements to optimize product development timelines and outcomes.
• Lead the evaluation and implementation of artificial intelligence (AI) tools to support and enhance all Regulatory Affairs functions, as appropriate.

2. Submission Management

3. Team Management & Development

4. Cross-Functional Collaboration

5. Regulatory Intelligence & Compliance

6. Emotional & Social Intelligence

KEY QUALIFICATIONS :

1. Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related discipline.

2. Minimum of 10 years of progressive Regulatory Affairs experience in the pharmaceutical or biotechnology industry.

3. Demonstrated experience with FDA regulatory submissions (e.g., IND, NDA) and successful agency interactions.

4. Proven ability to lead, mentor, and develop small, high-impact teams.

5. Demonstrated success in balancing strategic vision with tactical execution in a fast-paced, dynamic environment.

6. Strong experience in implementing risk-based decision-making processes in regulatory contexts.

7. Comprehensive knowledge of relevant FDA regulations, ICH guidelines, and global regulatory frameworks.

8. Strong project management and organizational abilities, with a track record of driving results.

9. Excellent written and verbal communication skills, including the ability to influence internal and external stakeholders.

PREFERRED QUALIFICATIONS :

1. Advanced degree (Ph.D., Pharm.D., or Master's) preferred.

2. Experience with global health authorities (EMA, Health Canada, MHRA) strongly preferred.

3. Drug development experience with DEA-regulated controlled substances preferred.

4. Background in psychiatric or central nervous system (CNS) drug development, particularly psychedelics, is highly valued.

PHYSICAL DEMANDS :

1. Ability to use a computer (Microsoft Office applications and other tools) for extended periods.

At Usona, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.