Messina is searching for a GxP regulatory submissions support SME/Expert to work remotely for an 8-12 month opportunity.

Providing Support as-needed in the area of GxP Regulatory Submissions:

GxP Regulatory Submissions, specifically has worked on:

  • Extensive (Expert/SME level) Biologic drug application/Submission regulatory affairs experience
  • Provided CMC regulatory affairs support and directly or indirectly for regulatory submissions
  • Compiled, supported Amendments and has experience filing Amendments to Drug (BLA/IND/ANDA/NDA) filings
  • NDA or BLA experience either in:
  • CMC sections and/or the other clinical sections of applications
  • Drug and biotech submission experience
  • i.e. ANDA, BLA, NDA, IND submissions
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GxP regulatory submissions support SME/Expert | Contract

Remote, IL

Messina is searching for a GxP regulatory submissions support SME/Expert to work remotely for an 8-12 month opportunity.

Providing Support as-needed in the area of GxP Regulatory Submissions:

GxP Regulatory Submissions, specifically has worked on:

  • Extensive (Expert/SME level) Biologic drug application/Submission regulatory affairs experience
  • Provided CMC regulatory affairs support and directly or indirectly for regulatory submissions
  • Compiled, supported Amendments and has experience filing Amendments to Drug (BLA/IND/ANDA/NDA) filings
  • NDA or BLA experience either in:
  • CMC sections and/or the other clinical sections of applications
  • Drug and biotech submission experience
  • i.e. ANDA, BLA, NDA, IND submissions

Learn More:

Mick Parks

Business Development Rep

mickparks@messinagroupinc.com

(847) 692-0614

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