Manager, Regulatory Affairs, Pharmacovigilance

If you find science, speed, and helping address serious infectious diseases exhilarating, you have come to the right place.

Individually, we're skilled, driven, and confident risk-takers.Collectively we're collaborative and accomplished. We're SuperNovas! Together we use our unique experiences, cultures, and learnings to turn innovation into reality while maintaining the highest standards. We value balance, encourage growth, and recognize that you are our most important asset. Build your future with us while bringing innovative vaccines to the world. We have a place for you!

Novavax, Inc (Nasdaq:NVAX) is a biotechnology committed to helping address serious infectious diseases globally through the discovery, development and delivery of innovative vaccines to patients around the world. We have more than a decade of experience contending with some of the world's most devastating diseases, and we are here to make a difference. Hard-won lessons and significant advances illustrate that our proven technology based on solid science tested by decades of research, has tremendous potential to make a substantial contribution to public health worldwide.

Job Summary

We are seeking a highly motivated and experienced individual to serve as a Manager on our Regulatory Affairs team. This position will report to the Senior Manager, Regulatory Affairs, Labeling Operations and Compliance. 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.

Essential Functions

• Oversight, planning, tracking, and execution of all regulatory submissions of PV documents to global regulators (e.g., responses to health authority requests, periodic safety update reports, periodic benefit-risk evaluation reports, 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.

• Manage and 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.

• Review of all individual and aggregate safety reports for compliance with regulatory requirements in both the pre-licensure and post-licensure setting.

• Review of clinical study safety documents (i.e., SMPs) to compliance with regulatory requirements

• Serve as regulatory liaison with cross-functional teams in Global Vaccine Safety and Pharmacovigilance.

• Maintain up-to-date working knowledge on 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.

• Develop and maintain regulatory processes and procedures, including SOPs, to ensure global regulatory/PV compliance.

Required Knowledge, Skills, and Abilities

• Demonstrated knowledge of pharmacovigilance regulations, processes, and systems within a drug development environment, notably with experience in implementing and executing regulatory/PV strategies to ensure global regulatory compliance for biological products.

• Experience managing individual case and aggregate 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.

• 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 within a remote 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 and familiarity with Veeva RIM system.

Education, Experience, Licenses & Certifications

• Bachelor's degree preferably in a scientific/medical field; advanced degree desirable.

• A minimum of 5 years in the biotechnology industry with at least 2 years in Regulatory Affairs with focus on PV