Regulatory Project Coordinator – Readiness to Execute (RTE)

Catalent Pharma Solutions; Saint Petersburg (FL); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Competitive PTO

Medical benefits

Dental benefits

Vision benefits

Tuition Reimbursement

Diversity & Inclusion ERGs

Wellness program

Job summary

Catalent Pharma Solutions in Saint Petersburg, FL is seeking a Project Management Coordinator to support the timely delivery of customer requests and regulatory documentation. You will work with scientists and project management to compile documents and ensure readiness to execute, contributing to batch manufacture and regulatory readiness.

The role emphasizes cross-functional collaboration, process improvement, and utilization of Quality, procurement, and supply chain systems to monitor

Qualifications

• Bachelor’s Degree required.
• Proficient knowledge of Microsoft programs required (Excel, Word, Access, and PowerPoint).
• Ability to work effectively under pressure to meet deadlines.
• Individual required to sit, stand, walk, and lift up to 15 pounds; no lifting greater than 44.09 pounds without assistance.
• Must be accessible to manufacturing floor and office staff and use required office equipment.
• Specific vision requirements include reading written documents and frequent use of a computer monitor screen.

Responsibilities

• Deliver customer requests and ensure deliverables are attained in support of readiness to execute (RTE).
• Work closely with scientists and project management to ensure on-time delivery of requested documentation.
• Support customer regulatory documentation compilation and follow‑up on document change requests to ensure timely execution within project timelines.
• Facilitate deliverables required to ensure readiness to execute (RTE) and support operations with all required documents for batch manufacture.
• Support the Quality Unit to ensure all required documents are in place to support batch release.
• Define and continuously improve key processes; escalated delayed deliverables to Project Management due to priority conflicts or other reasons.
• Collaborate cross‑functionally to translate product development milestones and effectively communicate with various levels within the organization.
• Learn and utilize Quality, Project Management, procurement, and supply chain systems to monitor documentation, project timelines, and logistics; take ownership of assignments, improve processes, and support special projects or smaller projects as assigned.
• Other duties as assigned.

Skills

Project coordination

Microsoft Office

Communication

Deadline-driven

Education

Bachelor's Degree

Tools

Microsoft Projects

Documentum

TrackWise

JD Edwards

Job description

Catalent Pharma Solutions in Saint Petersburg, FL is seeking a Project Management Coordinator to support the timely delivery of customer requests and regulatory documentation. You will work with scientists and project management to compile documents and ensure readiness to execute, contributing to batch manufacture and regulatory readiness.

The role emphasizes cross-functional collaboration, process improvement, and utilization of Quality, procurement, and supply chain systems to monitor