Associate Director, Regulatory Affairs

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Job description

This position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation for a religious belief or a health-related need.

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 an Associate Director position in Regulatory Affairs CMC. This position is located at our Gaithersburg, MD facility and will report to the Senior Director Regulatory Affairs CMC. The position will work in close collaboration with the Senior Director Regulatory Affairs CMC to implement and coordinate all aspects of regulatory activities as needed to support the global development of Novavax's investigational vaccines through licensure and beyond.

Responsibilities include but are not limited to:

* Assist with CMC regulatory submission strategies for investigational vaccine products.
* Lead key regulatory CMC activities, including planning, writing, and reviewing of documents necessary to support regulatory submissions, including INDs, IMPDs, CTAs, BLAs, MAAs, meeting requests, briefing packages, and responses to queries from regulatory agencies.
* Ensure that overall project timelines support the coordination and preparation of timely submissions.
* Communicate and coordinate with relevant functional groups and project team members to identify and ensure the preparation of required CMC documentation and data needed for regulatory submissions.
* Act as a liaison between the Regulatory CMC and Operations teams for submission content planning
* Assist with tracking comments from Health Authorities and post-approval commitments
* Maintain up-to-date working knowledge on relevant regulatory regulations, guidance, and the current regulatory environment. Provide updated information on regulatory CMC issues to project teams and other personnel.
* Establish regulatory CMC processes and procedures and provide training to other departments.

Minimum Requirements:

* Bachelor's degree preferably in a scientific field. An advanced degree is preferred.
* A minimum of 8-10 years in the biotechnology industry with at least 6 years in Regulatory Affairs CMC.
* Experience leading the preparation of INDs, IMPDs, CTAs, BLAs, MAAs and post-approval supplements
* Background in vaccine development with knowledge of vaccine drug product development highly desirable.
* Experience leading responses to queries from regulatory authorities during review
* Good understanding and experience with current GMPs and regulatory expectations for investigational products and clinical trials.
* Experience with CTD format and content.
* 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.

Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

Novavax, Inc. offers a base salary, annual bonus, stock options, 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, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.