Vice President, Head of Regulatory Affairs

<meta><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:0px;line-height:1.38;padding:0px;"><b><strong style="font-size:18pt;white-space:pre-wrap;">About the role</strong></b></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:0px;line-height:1.38;padding:0px;"><span style="white-space:pre-wrap;">The VP, Head of Regulatory Affairs is the company’s 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 hands-on execution, suited to a lean organization.</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:0px;line-height:1.38;padding:0px;"><br></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:0px;line-height:1.38;padding:0px;"><b><strong style="font-size:18pt;white-space:pre-wrap;">What you'll do</strong></b></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:16px 0px;line-height:1.38;padding:0px 0px 0px 32px;list-style-type:disc;"><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Portfolio &amp; Product Strategy </span></li><li style="list-style:none;font-size:11pt;margin:0px;line-height:1.38;"><ul data-pattern="discCircleSquare" data-depth="2" style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin-left:0px;margin-right:0px;line-height:1.38;padding:0px 0px 0px 32px;list-style-type:circle;"><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Define and continuously optimize global regulatory strategies (US/EU) for marketed and development programs. </span><span style="white-space:pre-wrap;"> </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Collaborate with internal customers, SMEs and other partners/stakeholders to ensure regulatory risk is factored in business plans and decisions. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Keep up-to-date and involved in the regulatory rare disease environment.</span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Lead informed go/no-go decisions cross-functionally. </span></li></ul></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Submissions &amp; Approvals</span></li><li style="list-style:none;font-size:11pt;margin:0px;line-height:1.38;"><ul data-pattern="discCircleSquare" data-depth="2" style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin-left:0px;margin-right:0px;line-height:1.38;padding:0px 0px 0px 32px;list-style-type:circle;"><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;"> Own and direct major submissions and label negotiations. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Ensure inspection readiness and submission quality. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Prepare and lead Health Authority meetings and Advisory Committee meetings. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Hands-on execution of regulatory activities in cross-functional collaboration. </span></li></ul></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Post-Approval &amp; Lifecycle Management (Commercial Products) </span></li><li style="list-style:none;font-size:11pt;margin:0px;line-height:1.38;"><ul data-pattern="discCircleSquare" data-depth="2" style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin-left:0px;margin-right:0px;line-height:1.38;padding:0px 0px 0px 32px;list-style-type:circle;"><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Set and execute LCM roadmap. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Accountable for regulatory compliance activities to maintain Marketing Authorizations world-wide (periodic reporting, fee payment, safety reporting, promotional material etc.). </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Support GxP compliance impacts on regulatory documentation, labeling and commitments.</span></li></ul></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Development Programs (Clinical &amp; CMC Integration) </span></li><li style="list-style:none;font-size:11pt;margin:0px;line-height:1.38;"><ul data-pattern="discCircleSquare" data-depth="2" style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin-left:0px;margin-right:0px;line-height:1.38;padding:0px 0px 0px 32px;list-style-type:circle;"><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Anticipate and steer expedited pathways and special designations. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Shape endpoints/COAs for rare diseases. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Drive CMC readiness for pivotal/registration. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Integrate patient voice and EAP/CUP considerations. </span></li></ul></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Leadership &amp; Organization </span></li><li style="list-style:none;font-size:11pt;margin:0px;line-height:1.38;"><ul data-pattern="discCircleSquare" data-depth="2" style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin-left:0px;margin-right:0px;line-height:1.38;padding:0px 0px 0px 32px;list-style-type:circle;"><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Build and develop a high-performing RA organization. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Foster talent development and mentorship to cultivate future regulatory leaders. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Establish operating rhythms and decision forums to ensure cross-functional communication, timely decision-making and tracking of progress. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Set and manage budgets and vendor strategy. </span></li></ul></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Governance, Quality &amp; Systems </span></li><li style="list-style:none;font-size:11pt;margin:0px;line-height:1.38;"><ul data-pattern="discCircleSquare" data-depth="2" style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin-left:0px;margin-right:0px;line-height:1.38;padding:0px 0px 0px 32px;list-style-type:circle;"><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Partner with QA on GxP compliance and inspection readiness. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Own RA systems and documentation flows. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Drive intelligence and policy monitoring. </span></li></ul></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Enterprise Impact </span></li><li style="list-style:none;font-size:11pt;margin:0px;line-height:1.38;"><ul data-pattern="discCircleSquare" data-depth="2" style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin-left:0px;margin-right:0px;line-height:1.38;padding:0px 0px 0px 32px;list-style-type:circle;"><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Advise Executive Team and Board on regulatory risk/mitigation. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Ability to effectively communicate with internal costumers, third-party partners, and regulatory authorities. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Represent the company externally at stakeholder meetings, conferences, and consortia.</span></li></ul></li></ul><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:0px;line-height:1.38;padding:0px;"><b><strong style="font-size:18pt;white-space:pre-wrap;">Qualifications</strong></b></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:16px 0px;line-height:1.38;padding:0px 0px 0px 32px;list-style-type:disc;"><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Required</span></li><li style="list-style:none;font-size:11pt;margin:0px;line-height:1.38;"><ul data-pattern="discCircleSquare" data-depth="2" style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin-left:0px;margin-right:0px;line-height:1.38;padding:0px 0px 0px 32px;list-style-type:circle;"><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;"> Advanced scientific degree or equivalent experience.</span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">15+ years in Regulatory Affairs with significant rare-disease expertise. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Strong expertise in US/EU Regulatory Affairs in all drug stages from development to commercialization and experience with roll-out to global markets. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Demonstrated leadership of major submissions and successful HA engagements. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Hands-on experience integrating CMC, clinical, nonclinical evidence. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Strong team leadership in resource-constrained settings. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Proficiency with eCTD, RA publishing, and EDMS tools. </span></li></ul></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Preferred </span></li><li style="list-style:none;font-size:11pt;margin:0px;line-height:1.38;"><ul data-pattern="discCircleSquare" data-depth="2" style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin-left:0px;margin-right:0px;line-height:1.38;padding:0px 0px 0px 32px;list-style-type:circle;"><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Experience with EAP/CUP, RWE strategies, COA/endpoint development. </span></li><li style="margin:0px;font-size:12pt;line-height:1.38;"><span style="white-space:pre-wrap;">Public speaking at AdComs or major scientific/regulatory forums.</span></li></ul></li></ul><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:0px;line-height:1.38;padding:0px;"><br></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:12pt;font-weight:400;margin:0px;line-height:1.38;padding:0px;"><b><strong style="color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;">Equal Employment Opportunity Statement</strong></b></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:12pt;font-weight:400;margin:0px;line-height:1.38;padding:0px;"><span style="font-size:12pt;white-space:pre-wrap;">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.</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:12pt;font-weight:400;margin:0px;line-height:1.38;padding:0px;"><br></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:12pt;font-weight:400;margin:0px;line-height:1.38;padding:0px;"><b><strong style="font-size:12pt;white-space:pre-wrap;">Notice to External Recruiters</strong></b><br><span style="font-size:11pt;white-space:pre-wrap;">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.</span></p> <meta><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:0px;line-height:1.38;padding:0px;"><b><strong style="white-space:pre-wrap;">About Zevra Therapeutics, Inc.</strong></b><br><br><span style="white-space:pre-wrap;">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.</span><br><br><span style="white-space:pre-wrap;">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.</span><br><br><span style="white-space:pre-wrap;">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.</span></p>