John L. Dancewicz
Regulatory Publishing Consultant
With over 13 years of experience in quality assurance and electronic document control, Mr. Dancewicz has supported a broad array of projects over the course of his career.
Mr. Dancewicz is responsible for planning, maintaining timelines and submitting eCTD submissions to Health Authorities (HA) assuring the quality and completeness of the submission. He reviews CMC documentation for consistency, quality, and compliance, and supports regulatory affairs to prepare eCTD submissions using industry templates while adhering to regulatory requirements.
- Life Cycle Management
- eCTD Formatting
- Technical Writing