The Supervisor combines hands-on submission oversight with workflow coordination responsibilities.
The Regulatory Operations Supervisor demonstrates commitment, integrity, and respect in all interactions.
- 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 escalate 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.
Skills Required
- 5+ years of experience 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
What We Do
Calcium+Company is an award-winning health communications group dedicated to nourishing companies and brands across their full lifecycle. To collaborate with a broad array of diverse clients and deliver innovative solutions, we’re organized around specialty divisions that include Calcium (healthcare marketing), Vitamin MD (medical communications), PRotein (public relations), Amino (oncology marketing), and Cobalt (commercial planning and market access). Our integrated strategy group, which combines brand, medical, and engagement strategy into one solution, works across Calcium+Company to deliver strategy grounded in behavioral science and data analytics. We are proud of our work but equally proud of our culture and were recently ranked one of MM+M’s 2024 Best Places to Work. Calcium+Company is led by CEO Judy Capano and Group President Greg Lewis. #nourishmentforlife
