Alliance Partner Regulatory Lead

10 Jul, 2022

Jobs

Alliance Partner Regulatory Lead

Novavax
Gaithersburg, MD

Job Details

Description

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:

The Alliance Partner and Rest of World (ROW) Regulatory Lead is responsible for the Novavax regulatory activities for the countries in Alliance Partner Region(s). The position will work in close collaboration with the rest of Global Regulatory Affairs organization and cross-functional Alliance teams to develop, implement, and coordinate all aspects of regulatory activities to support the global development of Novavax’s investigational products and to support the product license applications for the Alliance programs and ROW. This position will also manage staff responsible for country regulatory activities within the Middle East and Latin America. This position is located at the Novavax facility in Gaithersburg, Maryland and will report to the Vice President of Regulatory Affairs.

Serves as principal liaison for the company and health authorities, leads Agency meetings, negotiates regulatory pathways and country specific requirements with Agencies across multiple global regions

Evaluates, selects, and manages relationships with marketing authorization holders (MAH)

Manages ongoing relationships with global partners, and serves as the primary conduit, linking external and internal global regulatory programs

Provides briefings on Novavax global regulatory strategy to external partners, and provides updates on external regulatory programs within the organization

Establishes early-stage regulatory strategy across global markets, integrating new markets into existing regulatory programs while managing conflicting priorities and resources

Advises senior leadership across multiple business units, on regulatory strategy, and provides recommendations on how to integrate expanding business operations into existing product development and regulatory structure

Responsibilities include but are not limited to:

  • For the Alliance partner, provide country-specific requirements and regulatory strategies to support product licensure, product line extensions and application maintenance.
  • Develop strategies to efficiently streamline the use of regulatory documents to support multiple global regulatory filings.
  • For the region, lead the planning, oversight, management, and execution of country specific module 1 documents and expectations for emergency use authorizations, CTAs/CMA/MAAs, amendments/variations to support product licensure and post approval requirements. Identify risks and mitigations.
  • Review documents as appropriate for the region to support regulatory submissions, meeting requests, briefing packages, responses to queries from regulatory agencies.
  • With staff, act as Point-of-Contact with Regulatory Health Authorities and lead Health Authority meetings.
  • Ensure compliance with regulatory requirements and commitments.
  • Ensure that project timelines are aligned cross-functionally and support the coordination and preparation of timely regulatory submissions for the region.
  • Act as a key regulatory representative on internal and external project teams, including alliances/partners, to ensure that regional regulatory strategies are aligned within the global program.
  • Maintain up-to-date working knowledge on relevant regulatory regulations, guidelines and the current regulatory environment. Provide updated regulatory information and identify potential impact to project teams and management.
  • Develop and integrate regulatory processes and procedures applicable to the region.
  • Build support team and mentor multiple direct reports.

Minimum requirements:

  • Bachelor’s degree preferably in a scientific field; advanced degree desirable.
  • Background in vaccine or biologics development; expert knowledge of the vaccine development process is highly desirable.
  • A minimum of 15+ years in the biotechnology industry with at least 10 years in Regulatory Affairs and in-depth knowledge of worldwide regulatory requirements applicable in both the pre- and post-licensure setting.
  • Solid understanding of the drug development process, including experience with developing regulatory strategies for investigational products leading to product approvals.
  • Experience in staffing, managing and directing personnel and departmental activities.
  • Demonstrated effective working relationships with Regulatory Authorities, partners and vendors.
  • Effective in organizational cross-functional interactions.
  • Flexible, detail-oriented, and willing to work in a dynamic and fast-paced environment while managing multiple priorities. Show strong initiative and drive; must be an organized self-starter.
  • Strong communication skills (oral, written, and interpersonal); critical-thinking and ability to identify and recommend solutions to problems.
  • Experience leading meetings and negotiations with global health authorities
  • Experience reviewing and revising contracts with partners and public health agencies
  • Experience managing regulatory programs and establishing priorities, in a large global program with simultaneous applications for marketing authorization in multiple markets

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.

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Job posted: 2022-07-10