Senior Manager/Associate Director, Regulatory Affairs Submissions Clinical and Non-clinical

Novavax
Gaithersburg, Maryland, United States
Competitive
02 May 2022
01 Jun 2022
SENIO003229
Regulatory Affairs
Full Time
Permanent
Experienced (non-manager)

**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.

Summary of the Position:

We are seeking a highly motivated and experienced individual for a Senior Manager/an Associate Director position in Regulatory Affairs Clinical and Non-clinical. This position is located at our Gaithersburg, MD facility or remote, and will report to the Vice President of Regulatory Affairs Clinical. Non-clinical and Labeling. The position will work in close collaboration with the Vice President of Regulatory Affairs Clinical, Non-clinical and Labeling to implement and coordinate aspects of regulatory submissions activities as to support the global development of Novavax’ investigational vaccines through licensure and beyond.

Responsibilities include but are not limited to:

  • Assist with clinical and non-clinical regulatory submission strategies for investigational vaccine products.
  • Lead key regulatory activities, including planning, writing, and reviewing of documents necessary to support regulatory submissions, including INDs, 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 clinical and non-clinical documentation and data needed for regulatory submissions.
  • Act as a liaison between the Regulatory Affairs Clinical and Non-clinical , Regulatory Operations and project management 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.
  • Establish regulatory clinical and non-clinical submissions 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 12 years in the biotechnology industry with at least 8 years in Regulatory Affairs submissions and Project Management, management experience.
  • Experience leading the preparation of INDs, CTAs, BLAs, MAAs and post-approval supplements
  • Background in biologics development 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 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.

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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)