Position Overview
Job Description
The Sr. Regulatory Affairs Specialist will provide regulatory review and lifecycle support for advertising, promotional, labeling, packaging, digital, and other external-facing materials. This role evaluates claims, messaging, and content for compliance, accuracy, and alignment with regulatory requirements while guiding cross-functional teams and identifying risks.
Key Responsibilities:
- Review advertising, promotional, labeling, packaging, and digital materials for regulatory compliance and accuracy
- Evaluate claims, benefit statements, and product positioning for substantiation and regulatory impact
- Provide clear regulatory guidance and recommendations to cross-functional teams (Marketing, Medical, Legal, Quality, Operations, etc.)
- Coordinate regulatory review processes, consolidate feedback, and manage timelines and trackers
- Prepare and maintain documentation including approvals, submissions, and regulatory records
- Monito...