Associate Director/Director, Regulatory Intelligence


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Gaithersburg, MD

Job Description

As posted by the hiring company

Job Overview:

**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.

We are seeking an Associate Director/Director, Regulatory Intelligence. The successful candidate will provide global regulatory intelligence expertise, regulatory affairs, pre-clinical, clinical, and commercial areas for investigational and marketed products.  This candidate will ensure that regulatory/competitive intelligence, or scientific/regulatory information searching, summarization, assessment and dissemination are provided to the Novavax organizations. The Associate Director/Director will proactively monitor emerging external scientific and regulatory trends, approvals, and strategies to inform and influence the development of regulatory strategies and policies both across and within portfolio areas.  This candidate will work with Global Regulatory Affairs to provide both routine and ad hoc requested information including implementing a commenting process on health authority guidance and directives, lead development of Policy or Position Papers.

Reporting to the Vice President, Clinical Non-Clinical

Responsibilities include but are not limited to:

  • Under the direction of the Vice President, Clinical Non-Clinical provides strategic regulatory intelligence using both routinely timed reports and as well as targeted information to support both project and organizational activities. Designs programs for complete and accurate IND/CTA/BLA submissions and ensures that clinical trials are designed to meet regulatory requirements. Take independent and creative actions to determine solutions to meet the known and anticipated needs for the organization at both the product and organizational levels.
  • Develops and implements a health authority guidance and directive commenting process
  • In collaboration with Regulatory leadership develops and implements regulatory information tools and reporting methods
  • Interacts with providers of regulatory and competitive intelligence to ensure high quality sources of information.
  • Investigates and analyzes the regulatory precedence for Health Authority approvals for competitive products
  • Identifies the development programs used to support competitors’ license applications and the issues raised during the review process, including scientific advice and results of FDA Advisory Committee meetings.
  • Prepares and delivers regulatory intelligence newsletters on agreed schedule highlighting pertinent regulatory activities and potential impact on Novavax Business and products.
  • Supports Regulatory Policy initiatives through the delivery of research and analysis
  • Works with other functional including Tech Ops, Supply Chain, Commercial, Quality, Clinical, Nonclinical, project management etc. to develop solutions for need for regulatory intelligence e.g., manufacturing monitoring supplier report. For GMPs status, recalls, warnings etc.
  • Develops strong relationships with Regulatory Policy, government and corporate communications, and commercial competitive intelligence groups within Novavax through membership in cross functional task forces and projects
  • Work with regulatory strategists to support the development of strategies, health authority and other materials to support development and post marketing. Identify early all major regulatory issues and ensure these are communicated to relevant stakeholders in a timely manner.
  • Responsible for leading / facilitating global review for health authority and trade association guidance and position papers and submitting high level of quality final comments within timeframe allotted
  • Identifies and oversees outsourced suppliers of regulatory intelligence and assessments in the preparation and documents/reports. Will also do preparation of this information themselves and ensure good channels of communication for this information.  Work closely with search and information resource
  • May serve as part of Clinical Regulatory and labeling teams as needed.
  • Trains, and coaches internal and outsourced staff on regulatory intelligence sources and reporting methods
  • Supports or leads projects and non-project activities e.g. SOP/standards development, organizational initiatives, as needed. etc.
  • Comprehensive knowledge of the regulatory affairs intelligence and competitive drug, device, diagnostics databases and sources/environment.
  • Hands on experience and good understanding of the development and regulatory processes.
  • Proven success of in delivering easily consumable and comprehensive information materials as presentation or documents.
  • A background in the regulatory intelligence community and connections within the industry and related organizations is also beneficial

Minimum requirements:

  • B.S. in scientific with a higher advanced degree preferred
  • 12+ years of experience in Regulatory affairs and a similar position
  • Needs to be self-driven, motivated and can work independently in a matrix environment with a continuous improvement mindset
  • Demonstration of mental agility and pragmatism required
  • Strong information searching, summarization and assessment skills
  • Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
  • Strong analytical skills and problem-solving ability
  • Strong communication and presentation 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.