Senior Regulatory Affairs Consultant

Job Summary

A company is looking for a Senior Regulatory Affairs Associate / Regulatory Affairs Consultant in the United States of America, Remote.

Key Responsibilities:

• Provide operational support in the IND/NDA maintenance stage for a large, dedicated client
• Offer regulatory guidance to Project Teams for the development of regulatory submissions and ensure compliance with regulatory standards
• Manage, review, and organize documents intended for submission to FDA

Qualifications:

• 3+ years' experience in Pharmaceutical/Biotechnology, CRO, or Life Science Consulting industries
• Experience in General Regulatory Affairs with expertise in IND, CTA, MAA, NDA submissions
• Knowledge of FDA processes and regulations, familiarity with FDA interactions
• Previous small molecule experience preferred, medical device experience a plus
• Bachelor's Degree in a Scientific or Technical Discipline; Advanced Degree Preferred