Remote Regulatory affairs Jobs · Europe

• Prepare and compile regulatory dossiers for international markets.
• Coordinate and review administrative and technical documentation for new product registrations.
• Manage regulatory documents and data within Veeva Vault RIM.

• Support the management of crop protection product registration dossiers under EU Regulation 1107/2009.
• Review regulatory dossiers to ensure compliance with client quality standards and EU requirements.
• Lead planning, submission, and post-submission activities for new formulations and product renewal programs.

Provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. Coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable.