Regulatory Associate Director - EU Established Products

Key points about this job

• Leading the EU Regulatory team and representing the team at project meetings and ensuring global regulatory lifecycle management strategy and submission planning are executed efficiently
• Overseeing and performing all regulatory activities for assigned marketed products including participation in the development of European regulatory strategies for the product lifecycle, from MAAs through to post-marketing
• Accountability for all CP, DCP, MRP and national submissions and approvals of projects of responsibility, or overseeing direct reports responsible
• Provides oversight to ensure regulatory compliance of Marketed Products, including oversight of the product-related data in the registration database
• Serving as an expert in European regulatory guidelines, sharing your knowledge with the team and addressing challenges when they arise