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Biologics, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
4 Year Degree
Senior Specialist, Regulatory Affairs
The Senior Specialist Regulatory Affairs (RA) is responsible for the regulatory support of projects through product development, registration processes and life-cycle management as well as coordination of multidisciplinary regulatory project teams relevant to biological products of Bavarian Nordic.
Location: Local candidates (Triangle area NC) preferred; fully remote within Eastern or Central time zones in US will also be considered.
Responsible for interactions with US FDA and Health Canada, but potentially could include coordination of regulatory activities in Mexico, Europe, or other areas worldwide.
Responsible for regulatory support of vaccines, either investigational products in development, and/or marketed vaccines. BN currently has 3 marketed vaccines for prevention of defined infectious diseases, plus additional vaccines in development for several other infectious diseases, plus treatment vaccine candidates in development for various oncology indications.
Responsible for regulatory activities for drug development for designated projects: timely preparation, compilation and/or coordination of regulatory documents for designated projects e.g. Briefing Books, Investigational New Drug Applications (INDs), Clinical Trial Applications (CTAs), Orphan Drug Designations, Biologics License Applications (BLA)
Maintenance of regulatory life-cycle management for licensed products: timely preparation, coordination and submission of variations/supplements/annual reports, iCompilation and/or coordination of regulatory documents for these submissions e.g. US Product Information, Sections or Modules of Marketing Authorization Applications.
Responsible for regulatory support for commercialization of BN’s vaccines in United States (e.g. review of artwork, support review of promotional material as well as FDA submission of promotional materials).
Responsible for ensuring that the submitted applications are consistent with the company strategy goals; compliant with the current guidelines and send out in due time to the respective Competent Authority.
Responsible for coordinating the Competent Authority response team through the regulatory approval process for above mentioned procedures (e.g. timely compilation and/or coordination of regulatory response documents).
Responsible for reviewing pre-clinical and clinical documents (Protocol, Clinical Study Report, Investigator’ Brochure…) for scientific plausibility, accurateness and regulatory compliance
Will liaise with functional areas and team members (e.g. Clinical, Nonclinical, CMC, Regulatory, Commercial, Project Management) to ensure documents are compliant with internationally accepted submission guidelines, BN internal templates and BN authoring style guide.
Minimum 5 years of work experience in regulatory activities in drug development
Must be an effective problem solver and solution finder
Enthusiastic team player with a passion for regulatory affairs
Advanced knowledge of regulatory submission and approval processes
Familiar with interactions with FDA (knowledge of Health Canada, EMA and other agencies desired)
Experience in the development and registration of biologics desired
Excellent English written and verbal communication skills required
Knowledge of regulatory intelligence sources to provide accurate regulatory advice
High level of computer knowledge and skills (MS Word/Excel/PowerPoint/Project, controlled document systems, regulatory information management systems (e.g. VEEVA RIMS) Sharepoint, MS Teams)
Detail oriented at read out of scientific data for integration into regulatory documents
Telecommuting is allowed.
Internal Number: BN12345
About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacture and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and has been a long-term supplier to the U.S. Strategic National Stockpile of a non-replicating smallpox vaccine, which has been approved by the FDA, also for the protection against monkeypox. Our commercial product portfolio furthermore contains market-leading vaccines against rabies and tick-borne encephalitis as well as an Ebola vaccine, licensed to Janssen. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system.