Associate Director/Director, Regulatory Affairs (Nonclinical/Clinical)


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Gaithersburg, MD

Job Description

As posted by the hiring company

Job Overview:

**Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.**

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 Associate Director/Director position in Regulatory Affairs (Nonclinical/Clinical). This position is located at our Gaithersburg, Maryland facility and will report to the Senior Director of Regulatory Affairs. The position will work in close collaboration with the Regulatory Affairs and cross-functional teams to develop, implement, and coordinate all aspects of global regulatory activities with a primary focus on nonclinical and clinical regulatory strategy to support the continued development of Novavax’s investigational vaccines through licensure and beyond. This position will work primarily on COVID-19 Vaccine development and function as a country/regional lead.

Responsibilities include but are not limited to:

  • Lead the planning, oversight, management, and execution of BLAs/MAAs and their amendments/variations to support vaccine development both pre- and post-licensure, including developing strategies for indication expansion.
  • Work in collaboration with project teams to provide strategic regulatory guidance for licensure and beyond. Lead the development of global regulatory strategies for assigned countries/regions.
  • Develop strategies to most efficiently streamline use of regulatory documents to support multiple global regulatory filings; identify and track country-specific requirements and documents.
  • Lead and execute key regulatory activities, including planning, writing, and critical review of documents necessary to support regulatory submissions, including INDs/CTAs, BLAs/MAAs and amendments/variations, meeting requests, briefing packages, responses to queries from regulatory agencies, etc.
  • Critical review of regulatory clinical/nonclinical documents (eg, clinical study reports, Module 1/2 documents, etc) for compliance with regulatory requirements, alignment across documents, and to ensure specific requests from regulators are addressed, as applicable.
  • Ensure that project timelines are aligned cross-functionally and support the coordination and preparation of timely regulatory submissions globally.
  • Communicate and coordinate with relevant functional groups and project team members to identify and ensure the preparation of required documentation and data needed for regulatory submissions.
  • Act as primary regulatory representative on internal and external project teams, including Clinical Research Organizations (CROs) and other alliances/partners, to ensure that development activities support and comply with relevant regulatory requirements.
  • Maintain up-to-date working knowledge on relevant regulatory regulations, guidelines, and the current regulatory environment. Provide updated information on regulatory issues to project teams and other personnel.
  • Develop and establish regulatory processes and procedures and provide training to other departments.
  • Build supporting team and mentor multiple direct reports.

Minimum requirements:

  • Bachelor's degree preferably in a scientific field; advanced degree desirable.
  • A minimum of 12 years in the biotechnology industry with at least 10 years in Regulatory Affairs.
  • Background in vaccine or biologics development; expert knowledge of the vaccine development process is highly desirable.
  • Solid understanding of the drug development process, including experience with developing regulatory strategies for investigational products leading to licensure; experience leading at least 1 BLA or MAA is desired.
  • Strong understanding of ICH, GCP, GLP, and other global regulatory requirements applicable in both the pre- and post-licensure setting.
  • Flexible, detail-oriented, and willing to work in a dynamic and fast-paced environment while managing multiple priorities.
  • Show strong initiative and drive; must be an organized self-starter.
  • Ability to work independently, within a group setting, and interact effectively across cross-functional departments.
  • Strong communication skills (oral, written, and interpersonal); critical-thinking and ability to identify and recommend solutions to problems.
  • Advanced Microsoft Word 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.