Associate Director, Global Regulatory Affairs Business Operations and Policy

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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 an Associate Director, Global Regulatory Affairs (GRA) Business Operations.  The functions include but not limited to: Regulatory Development and Operations, Regulatory Clinical, Global labeling, Regulatory CMC, Regulatory Information Management and Publishing, Advertising and Promotion Compliance. This role will be responsible for assuring the GRA functional and cross-functional business practices are efficient, compliant with SOPs, establish best practices and drive process improvements.

Remote based candidates may be considered.

Responsibilities include but are not limited to:

  • Develop, implement, and oversee a global strategic plan for GRA on the projected demand, and other existing or developing business plans that will enable long term growth strategy and optimization of efficiency and financial compliance.
  • Develop and implement other business processes to facilitate the execution of functional activities within the GRA.
  • Work alongside both the partner and internal teams to optimize communications/performance and develop strategic, long-lasting partnerships.
  • Partner up with various HR sections to develop a good recruiting strategy and retention plan for GRA functions.
  • Manage monthly spend and contract requirements to ensure compliance.
  • Manage and oversee the annual budget planning process for the GRA.
  • Serve as a liaison between the GRA and all supporting functions such as finance, legal, and HR.
  • Work closely with all GRA functions to development and facilitate the implementation of continuous improvement.
  • Establish process and procedures to build cohesion within the GRA as well as with other Novavax functions.
  • Summarize core presentations for GRA team for various communication.
  • Coordinate and lead implementation of regulatory strategic initiatives.

Specific Skills and Knowledge:

  • Strong Regulatory experience and knowledge of operations in the Global Regulatory Affairs.
  • Strong experience working with PowerPoint, SharePoint systems, financial systems, budget tracking, review and approval of definitive contract agreements, contract terms & conditions, master service agreements, statements of work and Budget management
  • Experience working in multicultural international environments
  • Experience with Project / Portfolio Management
  • Experience with Operational Excellence and/or continuous improvement tools

Minimum requirements:

  • S. in scientific or management degree (MBA or JD preferred)
  • 10+ years of experience in Regulatory affairs and a similar position
  • Excellent track record in Partner, Vendor, Account and Project Management
  • Excellent track record in managing cross functional teams and clients
  • Needs to be self-driven, motivated and can work independently in a matrix environment with a continuous improvement mindset
  • Excellent verbal and written communication and presentation skills
  • Demonstration of mental agility and pragmatism required

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