Oferta de trabajo: Director Regulatory Affairs Usona

JOB REQUIREMENTS: 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 * 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.... For full info follow application link. Diversity is important at Promega. 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. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/5905DEB1669C4FBA Qualified females, minorities, and special disabled veterans and other veterans are encouraged to apply.