Regulatory Operations Coordinator

3 weeks ago


Philadelphia PA, United States Piper Companies Full time

Piper Companies is looking for a  Regulatory Operations Coordinator   to be responsible for supporting pre-IND and IND stage regulatory submissions to FDA working for a Biotechnology company in Philadelphia, PA .

 

Responsibilities for the Regulatory Operations Coordinator   include:

  • Work with internal teams and stakeholders to build IND & CTA dossier content plans and routine regulatory submissions
  • Lead interactions with publishing team to assemble IND or CTA submissions including annual reports, safety reports, protocol amendments, etc.
  • Support authoring and manage document workflows for planned major submissions

 

Qualifications for the Regulatory Operations Coordinator   include:

  • B.S. degree with 3+ years pharmaceutical/biotech industry experience including 2+ years regulatory affairs or regulatory operations experience.
  • Experience supporting regulatory submissions and managing document authoring and review workflows. 
  • Global Regulatory submission experience
  • Detail-oriented with expertise in FDA submission requirements and regulatory document authoring standards.

 

Compensation for the Regulatory Operations Coordinator   include:

  • 6-12 month consulting assignment, opportunity to extend/convert thereafter
  • Full Cigna Benefits: Medical, Dental, Vision
  • 2 weeks PTO, 6 Paid Holidays, 401k

Keywords: Regulatory Affairs, IND, CTA, Biotechnology, Cell & Gene Therapy, Regulatory submission

#pando #LI-DNP

PandoLogic. Keywords: Operations Specialist, Location: Philadelphia, PA - 19122

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