Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, and achieved positive Phase 1 clinical trial results. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.
For more information, visit the company´s web sites at: http://www.novavax.com
Manager Regulatory Affairs Adjuvant
Job Title: Manager Regulatory Affairs Adjuvant
Reports to: Director Quality Operations
Location: Uppsala, Sweden
Novavax is in a very exciting and stimulating phase going from research and developing to be a producing company with products on the market. Novavax are at the very forefront to be able to deliver a COVID-19 vaccine to fight the pandemic. They also have several of very interesting and important other vaccine candidates in their clinical program; seasonal influenza, RSV and collaboration with external partners for a malaria vaccine.
Novavx AB is looking for a highly motivated and experienced individual for a Manager position to lead Regulatory Affairs adjuvant strategies and submission to support their US-based Regulatory Affairs team. This position will report to Director Quality Operations (at Novavax in Sweden Uppsala) and will ideally be located at our Sweden facility. The position will work in close collaboration with the US Regulatory Affairs and cross-functional teams to develop, implement, and coordinate all aspects of adjuvant regulatory strategy and execution to support the global development of Novavax’s Matrix-M adjuvant through licensure and beyond.
Manager Regulatory Affairs Adjuvant will be responsible to lead and execute key regulatory activities, including planning, writing, and critical review of documents necessary to support adjuvant regulatory submissions, meeting requests, briefing packages, responses to queries from regulatory agencies etc. Earlier experience from vaccines (adjuvanted vaccines) or biologicals is a strong advantage.
We are looking for an experienced Regulatory Affairs Manager, preferable but not a must, with a background in vaccines or biologics with excellent skills developing regulatory strategies in Europe and rest or the world. You are strategic, analytical, and structured, and willing to work in a dynamic and fast-paced environment while managing multiple priorities. It is important to have strong communication skills, and to be ambitious with a personal drive to take responsibility, and with the ability to work both independently and together with others to deliver results.
Experience and qualifications
• Bachelor's degree preferably in a scientific field, advanced degree is desirable
• Long experience from the biotechnology industry and within Regulatory Affairs
• Background in vaccine or biologics development, and knowledge of the adjuvanted vaccine development process is highly desirable
• Solid understanding of the drug development process, including experience with developing regulatory strategies for investigational products leading to licensure. Experience of leading at least 1 CMA or MAA using the centralized procedure is highly desired
• Fluent in Swedish and English, oral and written
• Advanced skills in Microsoft office package (Word, Excel, Power point)
• 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
• Ability to work independently, within a group setting, and interact effectively across cross-functional departments
• Strong communication skills (oral, written, and interpersonal); critical-thinking and ability to identify and recommend solutions to problems
Opportunities with the role
• The possibility to work for a successful, growing, and innovative company in close collaborating with a very robust and mature “parent company”
• Work for a leading vaccine company that will enable patients’ worldwide access to safer and more efficient vaccines
• Be a part of the fight against Covid-19 with a vaccine at the forefront of research/development
• Become a leading key strategic player within Novavax AB with the opportunity to influence the strategy, way of working, company development and key decisions, and to contribute to the company´s future growth and development
• To work in a small company with a dynamic culture, freedom of action, a nice atmosphere and collaborative environment
• The company is in a very exciting and stimulating phase going from a research- and developing company to a producing company with products on the market
• Work in values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into vaccines to protect future pandemics and dangerous viruses as for example Covid-19
• Be part of a very competent and experienced team with high energy, all very committed to develop the company and the technology
• Work in a company with short decision paths and with a high level of personal responsibility
• Good possibilities to personal and professional development
For more information and questions about the position, please contact Marta Frick Senior Recruitment Consultant at PeakSearch.
Contact details: Marta Frick firstname.lastname@example.org Tel: 070-386 89 69