Senior Regulatory Operations Associate

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