Senior Regulatory Affairs Specialist

Job Summary

A company is looking for a Senior Specialist, Regulatory Affairs.

Key Responsibilities

• Develop and implement regulatory strategies for programs in all development phases
• Prepare and submit reports, amendments, and change notifications to regulatory agencies
• Assist in drafting and reviewing product labeling and regulatory documentation

Required Qualifications

• Bachelor's degree in a scientific discipline or equivalent experience
• At least 5 years of experience in laboratory, regulatory, or quality roles in relevant industries
• Specialist knowledge in US Regulatory Affairs and industry best practices
• Proficiency with eCTD software, Microsoft Office Suite, and Adobe Acrobat
• Experience with NDA submissions and combination products preferred; Regulatory Affairs Certification (RAC) strongly preferred