Regulatory Affairs Manager

• Coordinating, compiling and submitting Marketing Authorisation variations for existing approvals
• Composing and reviewing Pre-IND information packages and NDA packages for registration of prescription products in the US through the FDA
• Liaise with partner companies as the primary Regulatory Affairs contact for the company to achieve product registration in all new worldwide regions within projected timeframes
• Regulatory Affairs European project team leader for all new projects
• Interpreting EU and US regulatory guidelines and procedures and ensuring the regulatory compliance of the company in all new regions Establish and analyse department budget
• Identify and recommend areas for cost savings from and Regulatory and compliance perspective
• Provide Regulatory advice and feedback for all internal company departments and external partners
• Maintain and apply a high level of awareness and understanding of the impact of existing and future planned regulations