Senior Regulatory Science Specialist

Job Summary

Supporting US regulatory activities for pharmaceutical and biologic programs, the full-time Senior Regulatory Science Specialist will manage regulatory submissions, labeling, and compliance activities while collaborating with internal teams and client stakeholders in a remote environment.

Key responsibilities

• Support US regulatory activities for pharmaceutical and biologic products across multiple programs and clients
• Prepare, coordinate, and support regulatory submissions, registrations, and post-approval changes
• Collaborate cross-functionally with various stakeholders to ensure compliance with regulatory requirements

Required qualifications

• Experience supporting US regulatory activities for pharmaceutical and/or biologic products
• Familiarity with regulatory submissions, labeling, and lifecycle management
• Strong organizational skills with the ability to manage multiple projects and deadlines
• Effective communication and stakeholder management skills
• Experience in a consulting or client-facing environment is a plus