Regulatory Affairs Specialist - Brazil

Overview

Provide support for registration activity in your assigned geographic region(s); this includes (but is not limited to):

• Developing registration and launch plans with the regional sales managers.
• Preparation and submission of registration dossiers, and their remediation.
• Ensure compliance with Brazilian Licence Holder and BGMP requirements.
• Establish and maintain regulatory information systems such as technical documentation, quality records, routine reports and regulatory agency communications.
• Interpret existing and/or new regulatory requirements/guidelines and standards as they relate to company products and procedures.
• Ensure compliance to global regulatory requirements and company policies.
• Provide input to Company activities including the risk management process, process and procedure improvements, management review and support new product development activities
• Review document and p...