Careers

Senior Regulatory Affairs Specialist

If you are looking for an opportunity to advance your career in Regulatory Affairs, we may have an opportunity suited to you as our new Senior Regulatory Affairs Specialist, supporting clinical regulatory submissions in the US, Canada, and Europe as well as the materials related to corporate pipeline programs, while maintaining compliance with applicable regulatory requirements.

The Senior Regulatory Affairs Specialist, supports the global, VBI regulatory strategy.  This role works closely with the Director, Regulatory Affairs (North America), VP, Regulatory Affairs, Europe and Rest of Word (RoW), as well as clinical, analytical and manufacturing managers, to ensure compliance with global safety regulations for safety reporting, product candidate clinical trial requirements, labeling, and the design of permissible marketing communications.

Key Responsibilities

  • Supports regulatory activities for assigned projects in line with regulations and other applicable requirements to ensure compliance, including;
  • Review, compilation, and control of submissions and applications (IND, CTA, BLA, MAA, NDS)
  • Document and process changes to ensure accuracy, and completeness i.e; renewal submissions, change notifications, amendments, requests for information (RFI) and annual reports, as appropriate
  • With support from the Global Regulatory Project Manager, manage timelines and deliverables of regulatory documentation
  • Coordinate meeting requests, briefing documents, team preparedness
  • Keep abreast of laws/regulatory updates, communicate and disseminate intelligence that may affect ongoing programs
  • Support internal and external stakeholders including;
    • Internally across functional and development teams, Director, Regulatory Affairs (North America,) VP, Regulatory Affairs, Europe and RoW, QA team, and R&D
    • Externally with regulatory consultants and regulatory authorities
  • Participate in the Internal Audit program in compliance with all standards and regulations
  • Support development of clinical reports, and other adhoc reports, while ensuring regulatory compliance
    • Review, as required, the clinical sections of regulatory submissions to the Regulatory authorities

    Qualifications & Experience

    • 5 – 8 years’ experience in a related or substantially similar role i.e; Clinical Research Organizations, pharmaceutical companies, biotechnology environment, or Contract Research Organizations specializing in clinical data management, with a focus on regulatory documentation and regulatory submissions
    • Scientific background in clinical research, within a vaccine, infectious diseases and/or oncology environment
    • Growing and current knowledge of clinical regulatory guidelines and requirements
    • Familiar with major health authority interactions (e.g., FDA, EMA, BRDD) pre-IND and BLA/SA and MAA/pre-CTA and NDS, meetings, advisory committee meetings and/or oral explanations/scientific advice, etc.)
    • Previous experience in the preparation and submission of regulatory documents

    Skills and Abilities

    • Advanced analytical, organizational, time management and problem-solving skills with excellent attention to detail
      • Able to understand complex clinical, scientific, and technical information and to understand and interpret governing regulations and standards
      • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
      • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
    • Well-developed interpersonal and client relationship skills
    • Ability to work independently and/or as part of a team
    • Strong leadership skills to encourage and promote team collaboration within a dynamic and matrixed environment where balancing multiple and changing project priorities is common
    • Superior communication skills, including written, verbal, presentation, and negotiating skills
    • Proficient use of computer, software, and peripheral equipment, ie; MS Office, MS Mail/Outlook

    How to Apply

    If this describes you please introduce yourself by submitting your resume and cover letter outlining your qualifications and interest in joining VBI’s team to hr@vbivaccines.com.

    We thank all applicants for their interest, however, only those selected for an interview will be contacted.

    VBI is an Equal Opportunity Employer who firmly believes our diversity fosters innovation. Accommodations are available upon request for candidates with disabilities participating in all aspects of the selection process.

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