Regulatory Affairs Officer

Description:

Your role will be to prepare, contribute to and support their international registrations and Lifecycle activities for their current and actively growing range of pharmaceutical products.

Active member in a busy high quality globally focused regulatory team

Preparation and submit Life-Cycle Maintenance regulatory submissions for EU and global markets

Prepares and/or reviews regulatory documentation for submission to regulatory authorities.

Actively participates and employs effective communication practices with internal customers (CMC, Supply Chain, Quality, Clinical, Medical, Pharmacovigilance and ex global market Regulatory Managers).

Maintain status reports for assigned projects

Always perform assigned work according to current best good regulatory practice, SOPs and in compliance with current legislation and regulatory guidelines.