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