Regulatory Submissions Lead

Calcium+Company; Philadelphia (Philadelphia County); On-site; USD 90,000 - 130,000; Full time

Job summary

Calcium+Company seeks a Regulatory Operations Supervisor to manage daily regulatory submissions for clients, ensuring accuracy, proper formatting, annotations, and timely delivery in line with FDA requirements.

The role combines hands-on submission oversight with workflow coordination, quality control, and adherence to SOPs. Strong attention to detail and a proactive approach are essential for success.

Qualifications

• 5+ years in regulatory operations or submission management.
• Advanced experience with Veeva Vault or similar electronic review systems.
• Solid understanding of FDA promotional submission requirements.
• Strong attention to detail and organizational skills.

Responsibilities

• Oversee submission preparation, accuracy, formatting, annotation, and on-time delivery per client and FDA requirements.
• Coordinate workflow, track deadlines, allocate work across team members, and elevate risks as needed.
• Perform quality control checks on tagging, version control, and documentation; ensure SOP and template adherence.

Skills

Regulatory operations

Attention to detail

Project coordination

Team coordination

Tools

Veeva Vault

Job description

Calcium+Company seeks a Regulatory Operations Supervisor to manage daily regulatory submissions for clients, ensuring accuracy, proper formatting, annotations, and timely delivery in line with FDA requirements.

The role combines hands-on submission oversight with workflow coordination, quality control, and adherence to SOPs. Strong attention to detail and a proactive approach are essential for success.