Director/Associate Director, Regulatory Affairs
Novavax, Inc. (NASDAQ: NVAX), is a late-stage biotechnology company that drives improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax has a late stage quadrivalent influenza nanoparticle vaccine (NanoFlu), to address key factors that can lead to the poor effectiveness of currently approved flu vaccines. ResVax, an RSV vaccine for protection of very young infants via maternal immunization, is the only vaccine in a Phase 3 clinical program and is designed to prevent severe lower respiratory tract infection which is the second leading cause of death in children under one year of age worldwide. Novavax has also developed early stage products for emerging diseases based on its proprietary nanoparticle technology as well as it's Matrix adjuvant, currently in testing across all age demographics.
We are seeking a highly motivated and experienced individual for a Director/Associate Director position in Regulatory Affairs. 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 regulatory submission strategies for investigational and ultimately commercial vaccine products.
- Lead key regulatory 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 documentation and data needed for regulatory submissions.
- Act as primary regulatory 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 issues to project teams and other personnel.
- Establish regulatory 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 8-10 years in the biotechnology industry with at least 6 years in Regulatory Affairs.
- 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.