Senior Manager, Regulatory Operations

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 role of Sr. Manager, Regulatory Affairs is an integral member of the Regulatory Affairs department which is integral in advancing our programs. This role requires an individual with a collaborative and innovative approach to work with our cross-functional teams, and the ability to integrate all key elements of the program, facilitate discussion on progress, risks, impediments and concerns, and ultimately drive programs forward. This individual will deploy available tools to ensure program strategies are well defined and that teams can successfully execute against those plans within scope, budget and in a timely fashion.

This role is responsible for Regulatory Affairs functions across multiple programs that may span development through approval and launch.

What you'll do

Lead/Support activities including, but not limited to:

• Defines submission outlines, format, and quality requirements for electronic submissions; Coordinates and consults with other functional area staff on the content, review, and assembly of regulatory documentation. Ensures consistency, completeness, and adherence to standards for all regulatory submissions.
• Manages the tracking, compiling, publishing, quality checking, dispatching and archiving of Health Authority submissions. As needed, prepares and dispatches OPDP submissions. Manages and/or coordinates the activities of internal and external publishing staff contracted to publish and dispatch health authority submissions.
• Facilitates submission preparation via initiation of forms and creation of cover letters.
• Represents Regulatory Affairs and leads project teams for matters relating to electronic (and paper) submissions.
• Distributes and archives all incoming and outgoing communications with FDA and international counterpart agencies.
• Leads the implementation, validation, and operation of eCTD and electronic document management systems and other publishing and submissions technology