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Regulatory Affairs Analyst

Company Overview

Tyr is a management consulting and government affairs firm. We partner with our clients to tackle the most important challenges facing their organizations. We value performance and hold ourselves accountable to the highest standards.

Responsibilities and Duties

  • Support BARDA Program Office(s) as a subject matter expert in relevant field of experience(s) for vaccine, therapeutic, and/or antimicrobial advanced development; clinical and/or regulatory policy and/or manufacturing capacity construction
  •  Provide guidance documents and option papers on key issues related to the area(s) identified
  •  Review contract proposal and related documents
  •  Provide senior-level briefing(s) to ASPR/BARDA as required
  •  Prepare regular reports to ASPR/BARDA management on various technical issues identified 
  •  Provide project development level portfolio management and oversight
  •  Develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts
  • Provide subject matter expertise in regulatory affairs supporting MCM development pathways
  • Strategize innovative regulatory approaches to MCM development against emerging threats
  •  Advise regulatory and BARDA senior leadership on critical programmatic and project level regulatory challenges
  •  Provide training and advisement to BARDA staff on regulations, authoring regulatory documents, and interactions with regulatory authorities

Qualifications and Skills

  •  At least ten (10-15) years of relevant industry experience in pharmaceutical industry regulatory affairs positions; application of doctoral degree in biology, chemistry, or pharmacy with commensurate experience Deliverables would include work products related to the management of regulatory affairs strategic planning and guidance within current and planned BARDA vaccine, therapeutic, device/diagnostic, and/or antimicrobial advanced development and acquisition contracts.
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