Piper Companies is currently seeking a Sr. Regulatory Operations Specialist to support a growing and innovative cell and gene therapy company in Philadelphia, PA (Hybrid Schedule).

Responsibilities for the Sr. Regulatory Operations Specialist
• Coordinate diverse regulatory submissions by collaborating with internal teams and stakeholders, and develop content plans for IND & CTA dossiers.
• Lead interactions with external publishing teams to compile IND or CTA submissions, including reports and protocol amendments.
• Support drafting and managing document workflows for major submissions, overseeing interactions with external vendors and internal project teams.
• Complete administrative sections of IND/CTA submissions.
• Maintain regulatory systems and processes, including trackers, SharePoint sites, and file-sharing tools for external vendor communication.

Technical Requirements for the Sr. Regulatory Operations Specialist
• Bachelor's degree required, with over three years of pharmaceutical/biotech industry experience, including two years in regulatory affairs or operations.
• Proven track record in supporting regulatory submissions and managing document workflows.
• Preferred regulatory experience in various regions and technology/indications.
• Strong ability to manage regulatory workflows in cross-functional teams.
• Detail-oriented with expertise in FDA submission requirements and familiarity with cell and gene therapy regulatory standards in major markets like the US and EU.

Compensation & Benefits for the Sr. Regulatory Operations Specialist
• Compensation: $45-50/hr.
• Contract (with strong possibility of extension or possible conversion)
• Comprehensive Benefits package: Cigna Medical, Cigna Dental, Vision, 401k w/ ADP

Keywords: Regulatory, IND, CTA, SharePoint, Gene Therapy, Cell Therapy, Biotechnology, FDA, Pharmaceutical, Regulatory Submission

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