Regulatory Affairs Associate

Job Summary

A company is looking for a Regulatory Affairs Associate to support regulatory requirements for drug products.

Key Responsibilities

• Assist in the assessment and coordination of various pharmaceutical product types, including sterile injectables
• Develop and implement regulatory strategies for new and existing products
• Prepare, review, and submit regulatory documentation while maintaining regulatory files and archives

Required Qualifications

• Bachelor's degree in a related scientific discipline
• 2-5 years of experience in regulatory affairs within the pharmaceutical industry
• Knowledge of regulatory requirements for various drug product types
• Strong understanding of global regulatory requirements and guidelines
• Ability to travel as needed