Sr. Regulatory Operations Specialist

4 weeks ago

Elkins Park, United States Piper Companies Full time

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 LI-JM1 LI-HYBRID pando LI-DNP PandoLogic. Keywords: Regulatory Compliance Specialist, Location: Philadelphia, PA - 19122

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