Associate Director, Regulatory Affairs (Nonclinical/Clinical)
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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.
Summary of the Position:
We are seeking a highly motivated and experienced individual for an Associate 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’ 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.
- Bachelor's degree preferably in a scientific field; advanced degree desirable.
- A minimum of 10 years in the biotechnology industry with at least 8 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 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.
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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Gaithersburg, Maryland, USA
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