Regulatory Operations Supervisor

Calcium+Company•Philadelphia, PA

About The Position

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.

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.

Responsibilities

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.
Track submission deadlines and allocate work across team members.
Monitor workload distribution and escalate risks as needed.
Support timeline development in collaboration with Project Management.
Conduct quality assurance checks on tagging, version control, and documentation.
Maintain adherence to SOPs, templates, and publishing standards.
Identify opportunities to improve operational efficiency.