Senior Director, 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 Director position in Global Regulatory Affairs CMC.  The successful candidate 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 CMC regulatory strategy to support the continued development of Novavax’ vaccines through licensure and beyond. 

Responsibilities include but are not limited to:

  • Lead the planning, oversight, and management of BLAs/MAAs and their amendments/variations to support vaccine development both pre- and post-licensure.
  • Work in collaboration with project teams to provide strategic regulatory guidance for licensure and beyond.
  • Lead and execute key regulatory CMC activities, including planning, writing, and reviewing of 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.
  • Critical review of regulatory CMC documents for compliance with regulatory requirements, alignment across documents, and to ensure specific requests from regulators are addressed, as applicable.
  • 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 representative on internal and external project teams, including alliances/partners to ensure that development activities support and comply with relevant regulatory requirements.
  • Provide regulatory support for Health Authority inspections at manufacturing facilities.
  • 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.
  • Develop and establish regulatory CMC processes and procedures and provide training to other departments.
  • Mentor multiple direct reports.

Minimum Requirements:

  • Bachelor's degree preferably in a scientific field.  An advanced degree is preferred.
  • A minimum of 15+ years in the pharmaceutical/ biotechnology industry with at least 12 years in Regulatory Affairs.
  • Experience leading the preparation of INDs, IMPDs, CTAs, BLAs, MAAs and post-approval supplements.
  • Background in vaccine or biologics development is highly desirable.
  • Strong understanding of current GMPs and regulatory expectations applicable in both pre- and post-licensure environments.
  • Experience with CTD format and content.
  • Flexible, detail-oriented, and willing to work in a dynamic and fast-paced environment while managing multiple priorities.
  • Ability to work independently and within a group setting and to interact effectively with different functional departments.
  • Strong communication skills (oral, written, and interpersonal); critical thinking 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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