Regulatory Affairs Associate-Poland

The Regulatory Affairs Associate will support the preparation, tracking, and coordination of Ethics Committee (EC) and Regulatory Authority (RA) submissions. Under supervision, the Associate will assist the Regulatory Affairs team in ensuring that clinical trial submissions comply with applicable regulations and internal timelines.

More specifically, the Regulatory Affairs Associate must:

• Assist in the compilation and preparation of documentation required for EC and RA submissions.
• Support the tracking of submission timelines and maintain up-to-date regulatory trackers and databases.
• Assist in the preparation and submission of initial applications, amendments, and notifications under supervision.
• Help coordinate with IRB/IEC and internal teams to collect required documentation.
• Review and format documents for consistency and completeness prior to submission.
• Assist in adapting country-specific informed consent forms...