Vice President, Head of Regulatory Affairs

Vice President, Head of Regulatory Affairs About Zevra Therapeutics, Inc. We are a rare disease therapeutics company leading with science to make life-changing therapeutics available to patients with significant unmet needs. We involve key thought leaders, physicians, patients, care partners, and advocacy groups in all of our clinical and regulatory development strategies. With a keen understanding that drug development often requires creative solutions, we have the insight and expertise to forge new pathways to success that others have missed. By following the data without bias, our transparent narratives and common-sense perspective have successfully overcome complex development challenges to make much-needed therapies available to patients. Nimble and dauntless, we push boundaries beyond what is thought to be possible and advance new therapies that have the potential to bring meaningful improvement to patients lives. About the role The VP, Head of Regulatory Affairs is the companys senior regulatory executive and a member of the leadership team. This leader owns the global regulatory strategy and execution across the portfolio consisting of commercial products and development assets. The VP of RA demonstrates exceptional leadership skills and a passion for fostering professional growth within their team as well as improving the internal processes in the department. The role blends strategic leadership with handson execution, suited to a lean organization. What you'll do Define and continuously optimize global regulatory strategies (US/EU) for marketed and development programs. Collaborate with internal customers, SMEs and other partners/stakeholders to ensure regulatory risk is factored in business plans and decisions. Keep uptodate and involved in the regulatory rare disease environment. Lead informed go/nogo decisions crossfunctionally. Submissions & Approvals Own and direct major submissions and label negotiations. Ensure inspection readiness and submission quality. Prepare and lead Health Authority meetings and Advisory Committee meetings. Handson execution of regulatory activities in crossfunctional collaboration. PostApproval & Lifecycle Management (Commercial Products) Set and execute LCM roadmap. Accountable for regulatory compliance activities to maintain Marketing Authorizations worldwide (periodic reporting, fee payment, safety reporting, promotional material etc.). Support GxP compliance impacts on regulatory documentation, labeling and commitments. Development Programs (Clinical & CMC Integration) Anticipate and steer expedited pathways and special designations. Shape endpoints/COAs for rare diseases. Drive CMC readiness for pivotal/registration. Integrate patient voice and EAP/CUP considerations. Leadership & Organization Build and develop a highperforming RA organization. Foster talent development and mentorship to cultivate future regulatory leaders. Establish operating rhythms and decision forums to ensure crossfunctional communication, timely decisionmaking and tracking of progress. Set and manage budgets and vendor strategy. Governance, Quality & Systems Partner with QA on GxP compliance and inspection readiness. Own RA systems and documentation flows. Drive intelligence and policy monitoring. Advise Executive Team and Board on regulatory risk/mitigation. Ability to effectively communicate with internal costumers, thirdparty partners, and regulatory authorities. Represent the company externally at stakeholder meetings, conferences, and consortia. Qualifications Required Advanced scientific degree or equivalent experience. 15+ years in Regulatory Affairs with significant raredisease expertise. Strong expertise in US/EU Regulatory Affairs in all drug stages from development to commercialization and experience with rollout to global markets. Demonstrated leadership of major submissions and successful HA engagements. Handson experience integrating CMC, clinical, nonclinical evidence. Strong team leadership in resourceconstrained settings. Proficiency with eCTD, RA publishing, and EDMS tools. Preferred Experience with EAP/CUP, RWE strategies, COA/endpoint development. Public speaking at AdComs or major scientific/regulatory forums. Equal Employment Opportunity Statement Zevra is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Notice to External Recruiters Zevra does not accept unsolicited resumes from agencies or search firms. Recruiters are requested not to contact employees or hiring managers. All candidate submissions must be coordinated through our Human Resources team and require a prior written agreement. Any resumes sent without such an agreement will not create any implied obligation. #J-18808-Ljbffr