Are you looking for a challenging role that combines technical expertise with business acumen? TN Poland is seeking a highly qualified Principal Regulatory Affairs Consultant to lead their regulatory affairs efforts in Warsaw.

The successful candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval Chemistry, Manufacturing, and Controls (CMC) activities.

This role offers a unique opportunity for a highly qualified professional to develop and implement submission strategies for post-approval CMC activities, including variations, renewals, market expansions, and annual reports.

1. Develop and implement submission strategies and plans for post-approval CMC activities.
2. Assess change controls and provide regulatory assessments of quality changes in production and quality control.