BRTRC

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Regulatory Affairs SME

Regulatory Affairs SME

ID 
2017-2247
# of Openings 
6
Job Locations 
US-DC-Washington, DC
Posted Date 
9/8/2017
Category 
Program Support

More information about this job

Overview

BRTRC Federal Solutions is seeking Regulatory Affairs SMEs to support a government client in Washington, DC.  These positions are contingent on contract award.

Responsibilities

  • Support 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)
  • Prepare regular reports to 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 development pathways
  • Strategize innovative regulatory approaches to development against emerging threats
  • Advise regulatory and senior leadership on critical programmatic and project level regulatory challenges
  • Provide training and advisement to staff on regulations, authoring regulatory documents, and interactions with regulatory authorities

 

 

 

 

 

 

 

 

 

 

 

 

Qualifications

  • At least 10 - 15 years of relevant industry experience at senior regulatory affairs positions in the pharmaceutical industry
  • Application of doctoral degree in biology, chemistry, or pharmacy with commensurate experience

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