Senior Regulatory Operations Associate

Job Summary

A company is looking for a Senior, Regulatory Operations Associate (TEMP) to join their Regulatory Operations team.

Key Responsibilities

• Format and ensure compliance of submission level documents for electronic submissions
• Coordinate and publish components of various Regulatory Agency submissions
• Participate in the interpretation of health agency guidelines and lead projects to improve department processes

Required Qualifications

• Bachelor's degree in Science/Technology or equivalent experience
• 6+ years of experience in Regulatory Operations within the pharmaceutical or biotech industry
• Advanced skills in Microsoft Office Word, Adobe Professional, and relevant tools
• Proficiency in eCTD publishing tools such as docuBridge or Global Submit
• Current knowledge of global regulatory submission requirements and industry legislation