Novavax
  • 14-May-2021 to 14-Jun-2021 (EST)
  • Regulatory Affairs
  • Gaithersburg, MD, USA
  • Full Time - Exempt

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.  Novavax is currently conducting multiple late-stage clinical trials for NVX-CoV2373, our vaccine candidate against the virus that causes COVID-19, and has recently reported exciting and highly encouraging initial efficacy results. NanoFlu, our quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines. Our proprietary technology platform leverages the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

We are seeking a highly motivated and experienced individual for a Manager/Senior Manager position in Regulatory Affairs. This position will report to the VP Regulatory Affairs. The position will work in close collaboration with the Regulatory Affairs team and Subject Matter Experts to coordinate all aspects of regulatory activities associated with preparation and execution of Health Authority Meetings.

Responsibilities include but are not limited to:

Research, develop and coordinate by:

  • Drive coordination of preparation activities and follow-up on closure of actions needed to provide fully vetted and approved presentations in advance of the Health Authority Meetings.
  • Schedule slide prep, review, and rehearsal meetings to ensure timely submission of presentation and information to the Health Authority.
  • Take minutes during prep, review and rehearsal meetings and communicate and follow-up on action items with the presenters.
  • Using sharepoint, create folders for the different HA meetings with draft agendas and placeholder slides for presenters.
  • Follow-up and drive resolution of review comments made on the slides.
  • Ensure presentations are finalized in time to submit to the HA in advance of the Agency Meeting.
  • Maintain an up-to-date list of "Core" members required at the prep, review and rehearsal meetings as well as ensure that appropriate presenters and subject matter experts are invited to each meeting based on agenda topic.
  • Depending on the agenda topics propose an attendee list for the actual HA meeting.
  • Track status of review of meeting minutes and ensure follow up on items as needed to ensure timely issuance of meeting minutes.
  • Represent Regulatory Affairs on assigned product/ project teams to communicate regulatory strategy and plans to gain alignment with team members, line management, and multiple stakeholders.
  • Develop innovative regulatory strategies that incorporates risk identification and mitigation.
  • Provide critical review of documentation supporting regulatory meetings and communications, provide guidance to presenters to achieve regulatory objectives; anticipate Health Authority responses and communicate areas of risk to project teams and line management.
  • Drive meetings both in-person and teleconferences with regulatory agencies for specific projects.
  • Interpret existing regulations and guidance documents in support of regulatory communications.
  • As required, develop procedures to support the regulatory affairs department.

Minimum requirements:

  • BS in a related science field.
  • A minimum of 6-10 years in the biotechnology industry with 4-5 years in Regulatory Affairs.
  • Ability to work independently and within a group setting and to interact effectively with different functional departments across the organization.
  • Background in vaccine development with knowledge of the vaccine development process highly desirable.
  • Prior experience with Health Authority Interactions and Meetings is highly desirable.
  • Ability to work independently and within a group setting and to interact effectively with different functional departments.
  • Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
  • Shows strong initiative and drive; must be an organized self-starter.
  • Advanced skills in MS Word, MS Excel, MS PowerPoint, and Adobe Acrobat are essential.
  • Must be able and willing to work in a fast-paced environment while handling multiple priorities. Must be flexible, detail-oriented, and possess excellent analytical and problem-solving skills.
  • Ability to communicate and work successfully within a cross-functional team.
  • Excellent interpersonal and communication skills.

Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Equal Opportunity Employer/Veterans/Disabled

Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.

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