Senior Regulatory Affairs Specialist

Location

Dallas, TX

Type

Full-time

Summary

The Senior Regulatory Affairs Specialist is responsible for leading and executing regulatory activities to support compliance, product registrations, and lifecycle management activities across applicable markets. This role provides regulatory expertise to support submissions, renewals, labeling, promotional review, and ongoing compliance activities while ensuring alignment with regulatory requirements, internal procedures, and quality standards.

Key Responsibilities

• Lead preparation and management of regulatory submissions for product registrations, renewals, amendments, and post-approval changes.
• Ensure timely and high-quality regulatory approvals and maintenance of product licenses throughout the product lifecycle.
• Prepare and coordinate responses to regulatory authority inquir...