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 projects. This requires an in-depth understanding of company technology platforms. Examples include, but are not limited to, Veeva Vault, eCTD publishing tools (e.g. Lorenz DocuBridge, IQVIA RIMTools, GlobalSubmit), eDMS tools (e.g., Egnyte, ZenQMS, Documentum, SharePoint and other software tools and systems that may/are used by Regulatory).
- Leads the development, refinement, and implementation of internal SOPs, processes, procedures, work instructions and training programs for submission production and operational support activities. Leads the training of appropriate staff in the application of various standards and technologies including templates, document management practices, eCTD publishing, and other tools used within the company.
- Maintains a robust understanding of evolving Health Authority (HA) standards and procedures for regulatory submissions. Advises and/or trains project teams on new requirements, along with proposals for implementation.
- Responsible for maintaining application compliance schedules, including, but not limited to, annual reporting, periodic safety reporting, responses to health authority queries, etc.
- Responsible for maintaining logs of all communiques with health authorities, including but not limited to, submissions, planned and spontaneous communications, etc.
- Leads the creation of regulatory project plans and timelines for multiple projects or developmental programs. Maintaining publishing timelines and providing updates to senior management.
- Contributes to budgets, forecasts, and inquiries for Regulatory Affairs.
- Assists with the development of selected regulatory affairs content for submissions as needed. This development may include Health Authority forms, cover letters, and maintenance submissions (i.e., annual reports, Information amendments, safety reports, etc.).
Qualifications
Education and Experience:
- 9-11+ years’ experience in a fast-paced, high-volume document production environment (e.g., documentation, publications, electronic publishing) or clinical environment, preferably in the biotechnology/ pharmaceutical industry.
- Requires a detail-oriented self-starter with excellent organizational, planning, and follow-up skills, as well as communication, teamwork, and interpersonal skills.
- Ability to meet tight competing deadlines, juggle multiple priorities.
- Expert knowledge of regulatory submission publishing standards and procedures, including computer word processing, electronic document management systems, and regulatory publishing software.
- Robust understanding of FDA and other health agency regulations and guidance governing submission content and format.
- Excellent written communication and oral presentation skills
Competencies/Skills
- Strong personal leadership skills to drive performance and support corporate objectives.
- Ability to work collaboratively and effectively with others.
- Ability to work under pressure and meet deadlines.
- Strong analytical and communication skills.
- Well organized and detail oriented.
- Creativity and resilience in problem solving.
- Relentless hands-on drive to implement and accomplish performance goals.
- Effective management of vendor partners to ensure project scope is achieved within defined budget.
- Ability to independently research, design, and implement platform technology solutions.
