Regulatory Associate Director - EU Established Products
|Area||Central London, UK|
|Sector||Pharma / Biotech|
|Salary||£ 70,000 ~ 80,000 Competitive|
Working as part of an evolving Regulatory group, this EU leadership role will combine hands on technical project work and team management. You will provide a regulatory strategic focus for lifecycle management including variations / amendments, renewals, line extensions / MAAs.
London based 3 days per week with the flexibility to work from home 2 days per week.
Responsibilities will include:
· 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
Salary: Competitive base salary + Package
Interviews taking place over the next few weeks
For further information please get in touch with our lead consultant Natalie Jones on 0207 183 5059 or email your details directly to email@example.com