Position Summary

The Regulatory Affairs Specialist is responsible for supporting regulatory submissions and compliance activities for pharmaceutical, biotechnology, medical device, or related regulated products. This role manages regulatory documentation, supports post-approval changes, provides regulatory strategy, and ensures compliance with applicable domestic and international regulatory requirements. The position serves as a regulatory subject matter expert, collaborating cross-functionally to support product lifecycle management, regulatory submissions, labeling updates, and compliance initiatives.

Key Responsibilities

• Plan, author, compile, and submit regulatory filings and reports in electronic Common Technical Document (eCTD) format in accordance with applicable regulatory requirements.
• Review and assess Chemistry, Manufacturing, and Controls (CMC) changes and provide regulatory guidance for p...