Sr. Regulatory Operations Specialist

3 weeks ago

Philadelphia PA US 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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