Senior Specialist, Regulatory Affairs- Pharmacovigilance
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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.
We are seeking a highly motivated and experienced individual to serve as a Specialist/ Senior Specialist on our Regulatory Affairs team. This position is remote and will report to the Senior Manager, Regulatory Affairs, Pharmacovigilance. The position will work in close collaboration with the Regulatory Affairs and Pharmacovigilance (PV) teams to develop, implement, coordinate, and execute global regulatory and PV activities with a primary focus on ensuring global regulatory/PV compliance in the post-authorization setting, initially focusing on Novavax’s COVID-19 vaccine.
Responsibilities include but are not limited to:
- Tracking, and execution of all regulatory submissions of PV documents to global regulators (eg, responses to health authority requests, periodic safety update reports, periodic benefit-risk evaluation reports, monthly summary safety reports, etc) in collaboration with cross-functional teams and appropriate Clinical Research Organizations (CROs).
- Communicate and coordinate with relevant functional groups to identify and ensure the preparation of required documentation and data needed for regulatory/PV submissions, including responses to requests from health authorities.
- Track regulatory/PV health authority commitments and timelines in collaboration with key stakeholders.
- Ensure that timelines are aligned cross-functionally and support the coordination and preparation of timely regulatory submissions.
- Supports review of all regulatory/PV documents for compliance with regulatory requirements in both the pre-licensure (SUSAR reporting, DSURs) and post-licensure setting.
- May serve as regulatory liaison with cross-functional teams.
- Maintain up-to-date working knowledge of relevant regulatory regulations, guidelines, and the current regulatory environment, particularly with respect to PV management. Provide updated information on regulatory issues to project teams and other personnel.
- Assist in developing regulatory processes and procedures, including SOPs, to ensure global regulatory/PV compliance.
Education & Experience Requirements:
- Bachelor's degree preferably in a scientific/medical field; advanced degree desirable.
- A minimum of 4 years in the biotechnology industry with at least 3 years in Regulatory Affairs with a focus on PV.
- Demonstrated knowledge of pharmacovigilance regulations, processes, and systems within a drug development environment, preferably with vaccines or biologics.
- Experience submitting individual safety reports (eg, SUSARs, PSUR, PBRER, PADER, etc).
- Strong understanding of ICH, GCP, and other global regulatory requirements applicable in the PV setting both pre- and post-licensure.
- Solid understanding of the drug development process, notably with experience in implementing and executing regulatory/PV strategies to ensure global regulatory compliance.
Key Skills and Competencies:
- 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 with minimal supervision, 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.
- Advanced Microsoft Word skills.
Every day our employees impact the future of health by preventing disease. To recognize their contributions, we offer them performance-based pay; a flexible, welcoming work environment; comprehensive and competitive benefits.
Novavax is headquartered in Gaithersburg, Maryland. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious diseases.
Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals 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 protected characteristic.
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)
Gaithersburg, Maryland, USA
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