Associate Director Regulatory Affairs CMC Facilities


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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 creates transformational vaccines that address some of the world’s most pressing infectious diseases. We have more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.

Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform.  Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.

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 an Associate Director Regulatory Affairs CMC Facilities position. This position is located at our Gaithersburg, MD facility and will report to the Director of Regulatory Affairs CMC.  The position will work in close collaboration with the Director of Regulatory Affairs CMC to implement and coordinate CMC regulatory activities with a primary focus on Facilities to support the continued development of Novavax' investigational vaccines through licensure and beyond.   

Responsibilities include but are not limited to:

  • Lead regulatory CMC activities, including planning, writing, and reviewing of Facilities CTD sections/documents necessary to support regulatory submissions, including BLAs, MAAs, post-approval variations/supplements, meeting requests, briefing packages, and responses to queries from regulatory agencies.
  • Ensure that project timelines support the coordination and preparation of timely submissions.
  • Communicate and coordinate with relevant functional groups and project team members to ensure the preparation of required CMC Facilities documentation and data needed for regulatory submissions.
  • Responsible for regulatory assessment of Facilities related change controls
  • Provide regulatory support for Agency inspections and site visits
  • Act as regulatory CMC Facilities representative on project teams to ensure that activities support and comply with the relevant regulatory requirements.
  • Participate in project-related discussions and provide strategic, scientific, and regulatory affairs input for Facilities related aspects of given project.
  • Identify and escalate regulatory issues, and propose mitigation strategies
  • Maintain up-to-date working knowledge on relevant regulatory regulations, guidance, and the current regulatory environment.

Minimum Requirements:

  • MS or Ph.D. in a biological science or related discipline.
  • A minimum of 10 years in the biotechnology industry with at least 8 years in regulatory affairs.
  • Background in vaccine development with knowledge of the vaccine development process is highly desirable.
  • Experience with post-approval changes (variations and supplements)
  • Good understanding and experience with current GMPs and regulatory expectations for investigational and commercial products.
  • Experience with CTD format and content.
  • Ability to work independently and within a group setting and to interact effectively with different functional departments.
  • Ability to work in a fast-paced and dynamic environment with changing priorities.
  • Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.

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.