Regulatory Operations Coordinator

3 weeks ago


Elkins Park, 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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