Generic pharmaceutical regulatory expert

Regulatory Affairs Specialist

This role is responsible for ensuring full compliance with applicable European regulatory standards across a portfolio of generic pharmaceutical products.

The position involves oversight of product development documentation, preparation of regulatory submissions, and collaboration with external partners and regulatory agencies. The successful candidate will have experience with DCP procedures, dossier preparation, and generic product development.


Main Responsibilities:


The ideal candidate will be able to ensure adherence to the Quality Management System for all regulatory processes and contribute to team meetings and knowledge-sharing initiatives.


Requirements:


The successful candidate will possess solid knowledge of European and international regulatory frameworks, including EMA and ICH guidelines, and have understanding of regulatory planning and familiarity with end-to-end processes in generic product lifecycle.

Key Skills and Qualifications: