Associate Director/Director, Regulatory Affairs
Novavax, Inc. (Nasdaq:NVAX), is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. NanoFlu, its quadrivalent influenza nanoparticle vaccine, is currently in a pivotal Phase 3 clinical trial to address key factors that can lead to the poor effectiveness of currently approved flu vaccines. ResVax, its RSV vaccine for infants via maternal immunization, is the only vaccine to demonstrate efficacy in a Phase 3 clinical trial. Novavax recently initiated development of a vaccine program against COVID-19. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic nanoparticles addressing urgent global health needs.
We are seeking a highly motivated and experienced individual for an Associate Director/Director position in Regulatory Affairs CMC. This position is located at our Gaithersburg, MD facility and will report to the Vice President of Regulatory Affairs. The position will work in close collaboration with the Vice President of Regulatory Affairs to implement and coordinate all aspects of regulatory activities as needed to support the continued development of Novavax’s investigational vaccines.
Responsibilities include but are not limited to:
- Assist with CMC regulatory submission strategies for investigational and ultimately commercial vaccine products.
- Lead key regulatory CMC activities, including planning, writing, and reviewing of documents necessary to support regulatory submissions, including INDs and BLAs, 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 primary regulatory CMC representative on internal project teams and for other project development activities to ensure that development activities support and comply with the relevant regulatory requirements.
- 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.
- Bachelor’s degree preferably in a scientific field. An advanced degree is desirable.
- A minimum of 10 years in the biotechnology industry with at least 8 years in Regulatory Affairs CMC.
- Background in vaccine development with knowledge of the vaccine development process highly desirable.
- 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, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden. 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.
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Job posted: 2020-07-17