Regulatory Operations Coordinator
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 - 19122Estimated Salary: $20 to $28 per hour based on qualifications.
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