Senior Regulatory Affairs Specialist

Job Summary

Supporting US regulatory activities for Animal Health pharmaceutical and biological products, the full-time Senior Regulatory Affairs Specialist will manage labeling development, regulatory submissions, and compliance activities while collaborating with cross-functional teams in a remote environment.

Key responsibilities:

• Coordinate labeling development, review, approval, and maintenance for Animal Health products
• Prepare and manage regulatory submissions, registrations, and post-approval changes
• Evaluate product and labeling changes for regulatory impact and maintain documentation

Required qualifications:

• Bachelor's degree in a scientific, regulatory, pharmaceutical, or related discipline
• Five or more years of experience in regulatory affairs, labeling, or related fields
• Experience with regulatory submissions and lifecycle management
• Certification in clinical research or regulatory affairs preferred
• Experience working with cross-functional teams in a regulated environment