Director, Regulatory Affairs - Usona Institute

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
* Oversee the preparation, review, and submission of high-quality regulatory filings (INDs, NDAs, amendments, annual reports, meeting materials, etc.) to FDA and global health authorities.
* Ensure timely and accurate responses to regulatory queries and ongoing compliance throughout the product lifecycle.
* Define and manage submission timelines, incorporating innovative tools or strategies to ensure efficiency.

3. Team Management & Development
* Lead, mentor, and grow a team of regulatory affairs professionals to ensure effective planning and execution of regulatory activities.
* Foster a culture of collaboration, inclusion, and professional growth within the regulatory team.
* Provide ongoing training and professional development opportunities to enhance regulatory expertise and overall team performance.

4. Cross-Functional Collaboration
* Partner with internal stakeholders (e.g., CMC, Clinical Operations, Clinical Development, Nonclinical, Quality) to integrate regulatory requirements into development plans.
* Collaborate with external partners (CROs, consultants, etc.) to support strategic and tactical regulatory needs.
* Translate strategic regulatory goals into actionable project plans, ensuring efficient execution of operations, including submission timelines, vendor management, and inter-departmental coordination.
* Monitor and manage the tactical implementation of regulatory projects, addressing barriers to execution and escalating issues promptly to maintain timelines.

5. Regulatory Intelligence & Compliance
* Maintain up-to-date knowledge of relevant regulations, guidance, and drug development landscapes in the U.S. and internationally.
* Interpret regulatory requirements to ensure compliance, mitigate risks, and identify opportunities for accelerated development paths.
* Proactively communicate significant regulatory changes and their potential impact to senior leadership and cross-functional teams.
* Ensure adherence to ethical, legal, and regulatory requirements applicable to Usona's business.

6. Emotional & Social Intelligence
* Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with Act with kindness, curiosity, and respect for others.
* Embracing and being open to incorporating Emotional & Social Intelligence (ESI) core principles in daily work.
* Understands and complies with ethical, legal and regulatory requirements applicable to our business.

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 are committed to building a diverse workforce that reflects the communities we serve and creating a culture where everyone belongs. As an Equal Opportunity Employer, we welcome and encourage applications from all backgrounds, ensuring that employment decisions are made fairly and equitably.