Senior Manager, Regulatory Affairs CMC

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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 a Senior Manager position in Regulatory Affairs CMC. This position is located at our Gaithersburg, MD facility and will report to the Associate Director-Analytical Lead of Regulatory Affairs CMC. The position will work in close collaboration with the Regulatory Affairs CMC Team to implement and coordinate regulatory activities with a primary focus on analytical methods/control strategy to support the continued development of Novavax' investigational vaccines through licensure and beyond.   

Responsibilities include but are not limited to:

  • Manage key regulatory CMC activities, including planning, writing, and reviewing of analytical sections/documents necessary to support regulatory submissions, including INDs, IMPDs, CTAs, BLAs, MAAs, and their supplements/variations, meeting requests, briefing packages, and responses to queries from regulatory agencies.
  • Manage CMC regulatory submission strategies pertaining to Analytical submissions for US and International markets.
  • Act as regulatory CMC analytical representative on project teams to ensure that development activities support and comply with the relevant regulatory requirements.
  • 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.
  • Provide regulatory guidance on development and maintenance of analytical control strategy.
  • Provide strategic input on test method development, validation, verification, and transfer to ensure compliance with regulatory standards.
  • Maintain up-to-date working knowledge on relevant regulatory regulations, guidance, and the current regulatory environment.
  • 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 desirable.
  • A minimum of 8 years in the biotechnology industry with 5+ years preparing analytical sections of regulatory dossiers (IND, BLA, MAA).
  • Background in vaccine development with knowledge of the vaccine development process is highly desirable.
  • Expert knowledge of analytical methods for characterization, release, and stability testing of biologics is a must (vaccines preferred).
  • Good understanding and experience with current GMPs and regulatory expectations for investigational and commercial products.
  • Experience with CTD format and content.
  • Ability to work independently and within a group setting and to interact effectively with different functional departments.
  • Ability to work in a fast-paced and dynamic environment with changing priorities.
  • 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.

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.

#LI-BH #LI-remote

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)

Job details
Regulatory Affairs
Remote - US
Gaithersburg, Maryland, USA
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