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