Regulatory Operations Coordinator - Philadelphia, United States - Piper Companies

Description

Piper Companies is looking for a Regulatory Operations Coordinatorto 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 Coordinatorinclude:

• 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 Coordinatorinclude:

• 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 Coordinatorinclude:

• 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

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