Vice President, Head of Regulatory Affairs
- Full-time
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 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.
What you'll do
- Portfolio & Product Strategy
Define and continuously optimize global regulatory strategies (US / EU) for marketed and development programs.
Own and direct major submissions and label negotiations.
Set and execute LCM roadmap.
Anticipate and steer expedited pathways and special designations.
Build and develop a high-performing RA organization.
Partner with QA on GxP compliance and inspection readiness.
Advise Executive Team and Board on regulatory risk / mitigation.
Qualifications
Advanced scientific degree or equivalent experience.
Experience with EAP / CUP, RWE strategies, COA / endpoint development.
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.
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