Regulatory Operations Supervisor

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

The Regulatory Operations Supervisor manages the day-to-day execution of regulatory submissions. This role ensures submission materials are accurate, properly formatted, fully annotated, and delivered on time in accordance with client and FDA requirements.

The Supervisor combines hands‑on submission oversight with workflow coordination responsibilities.

The Regulatory Operations Supervisor demonstrates commitment, integrity, and respect in all interactions.

Key Job Responsibilities (Duties may include, but are not limited to all or some of the following)

Submission Preparation & Oversight:

• Upload tactics and supporting references into client electronic review systems (e.g., Veeva Vault).
• Link medical claims to approved references accurately and consistently.
• Insert required annotations, notes, and functional comments.
• Validate screenshots, documentation, and compiled submission files for completeness and accuracy.

Workflow Coordination:

• Track submission deadlines and allocate work across team members.
• Monitor workload distribution and elevate risks as needed.
• Support timeline development in collaboration with Project Management.

Quality Control:

• Conduct quality assurance checks on tagging, version control, and documentation.
• Maintain adherence to SOPs, templates, and publishing standards.
• Identify opportunities to improve operational efficiency.

Job Qualifications (Skills/Requirements)

• 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.