Job Summary

A biopharmaceutical company needs applicants for an opening for a Remote Regulatory Affairs Consultant.

Core Responsibilities of this position include:

• Managing the preparation, submission, and maintenance of regulatory submissions
• Leading or supporting development of DSUR, and any additional submission documents
• Interfacing with CMC, nonclinical and clinical teams on regulatory-related activities

Qualifications Include:

• Bachelor's degree in Life Sciences required
• 2 Years of Regulatory submission experience required
• Strong organizational, writing, problem solving, collaboration and communication skills is required
• Knowledge of US FDA and international pharmaceutical requirements, regulations, drug development process