Regulatory Specialist - Remote

Overview

The Regulatory Specialist oversees, educates, and advises on the medical, legal, and regulatory (MLR) aspects of promotional material development.

In Short

• Ensure the accuracy and integrity of promotional content for healthcare clients.
• Adhere to FDA regulations and client-specific requirements.
• Oversee regulatory-related efforts including submission preparation.
• Educate team members on regulatory processes and requirements.
• Advise on regulatory risk considerations for projects.
• Contribute to documentation on regulatory compliance.
• Collaborate with the Creative team on resource development.
• Conduct quality assurance on submissions for compliance.
• Track submissions through client MLR review processes.
• Participate in client MLR review meetings for clarification.

Requirements

• Deep understanding of FDA regulations and MLR processes.
• Experience in regulatory compliance and submission preparation.
• Strong communication and collaboration skills.
• Attention to detail and quality assurance capabilities.
• Ability to educate and train team members.
• Experience in documentation and content accuracy.

Benefits

• Opportunity to work with healthcare clients.
• Collaborative team environment.
• Professional development and training opportunities.
• Flexible work arrangements.