Regulatory Operations Associate

Time zone
Type
Full Time
Opening date
Closing date
5 Nov 2021
Views
111

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration.

Vaxart has demonstrated that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immuno-oncology indication.

Our mission is the promotion of global health through the development of effective vaccines that can be administered by tablet rather than by injection, providing for the simple and efficient distribution and administration of safe vaccines in any setting.

We are looking for a Regulatory Operations Associate to join our growing team!

Summary:

The Regulatory Operations Associate is responsible for participating in day-to-day departmental functions and activities in support of regulatory submissions for Vaxart’s vaccine candidates across multiple indications and INDs/CTAs. The Associate will have primary responsibility for departmental archives/records and will manage submissions for assigned products/studies. The Associate will function as a representative of the Regulatory group at interdepartmental settings. The Associate exercises judgment within defined procedures and practices to determine appropriate actions and resolve a variety of issues.

Responsibilities:

  • Participates in driving Regulatory Operations functions at Vaxart.
  • Responsible for global regulatory submission / dossier day-to-day activities and deliverables.
  • Manage the archival of agency correspondences, submission sequences, and other regulatory documents within the EDMS system.
  • Prepare for upcoming submissions and keep the project teams informed of pending regulatory activities. Review plans and announce upcoming dates as applicable to projects and assignments.
  • Communicate expectations and the timing of deliverables, both within the regulatory group and with program management.
  • Coordinate the delivery of a variety submission types, including INDs and amendments, annual reports, safety reports, etc.
  • Perform quality checks of others’ work.
  • Format basic to highly complex submission documents to ensure electronic submissions meet required standards and technical requirements within specified timelines.
  • Coordinate the review process of controlled documents and reports (from authoring to approval), both internally and externally.
  • Coordinate with Publisher to ensure timelines are met while high quality and accuracy is maintained for all dossiers and documents submitted by Vaxart.
  • Participate in department projects to improve department systems and processes. Participate in EDMS implementation and maintenance.
  • Participate in the writing and reviewing of Regulatory Operations work practices and Standard Operating Procedures (SOPs).

Requirements:

  • BA or BS, preferably in the field of science (BS or BA in Science/Technology), or an equivalent combination of education and experience preferred.
  • 5+ years of proven Regulatory Operations responsibilities including the submission of applications and reports to Health Authorities.
  • Experience in formatting/publishing/archiving.
  • Excellent verbal and written and editing skills.
  • Strong organizational and time management skills are required.
  • Ability to work under minimal direction, identify problems independently, and to seek help in resolution when needed.
  • Ability to act as the primary contact for assigned projects and represent Regulatory Operations on associated project teams.
  • Strong problem‑solving skills in relation to submission publishing.
  • Ability to work effectively within an environment that has quickly changing processes, priorities, and deadlines.
  • Strong attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents.

Computer Skills:

  • Fluent in the use of Microsoft Office Word, Adobe Professional, Excel functions, Project, SharePoint.
  • Experience in web-based content and document management environments and file transfer sites (EDMS solutions).
  • Familiar with US, CA, and EMA template and publishing standards.
  • Basic understanding of IT infrastructure.

Vaxart offers team members a competitive compensation and benefits package, including a bonus program, stock options, 401(k) with employer matching, tuition assistance, and work life balance.

Vaxart is an Equal Opportunity Employer and values diversity. We are committed to the principles of equal employment opportunity and affirmative action for all applicants and employees. Equal opportunity and consideration are afforded to all qualified applicants and employees in personnel actions, which include: recruiting and hiring, selection for training, promotion, rates of pay or other compensation, transfer, discipline, demotion, layoff or termination. Vaxart does not unlawfully discriminate on the basis of race, color, religion, sexual orientation, marital status, pregnancy, gender identity, gender expression, family medical history or genetic information, citizenship, national origin or ancestry, sex, age, physical or mental disability, medical condition, veteran status, military status, or any other basis protected by federal, state or local law, ordinance or regulation.

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