Amgen Director Regulatory Affairs Europe in Uxbridge, United Kingdom
Title: Director Regulatory Affairs Europe
Amgen is one of the world’s leading independent biotechnology companies, with global revenues in excess of $20 billion and over 20,000 employees. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.
The role: This role will involve both project management of a portfolio of products in addition to line management of a number of regulatory professionals with different levels of experience in the oncology therapeutic area for Europe and strategic input into the filing plans for several expanded European markets including Russia, Israel, the Baltic States and Switzerland.
The purpose of this role is:
The role will provide regulatory leadership, technical expertise including strategic guidance, and execution for the development, registration, and lifecycle management of a portfolio of products. The role will require defining innovative regulatory strategies for accelerating the development of the oncology portfolio, challenging regulatory precedence and risk taking as well and interpreting the external regulatory environment and precedence in advancing Amgen’s portfolio.
To provide management and leadership by advising/defining the development and execution of regulatory strategy and plans for regulatory agency interactions within his or her assigned area
To ensure appropriate regulatory input (including strategic impact) is provided into regulatory plans
To provide strategic oversight to European Regulatory Leads in technical procedures including regional regulatory activities
To strategically support European Regulatory Leads during European regulatory agency interactions
To facilitate patient access to Amgen products by ensuring adequate resources for regulatory filing plans within assigned area
To manage forums for sharing of best practices and lessons learned related to regional regulatory activities
Build internal and external networks with key stakeholders to influence regulatory outcomes
Interpret the external regulatory environment and regulatory precedence for assigned projects
Influencing and shaping the external regulatory environment
• Development and execution of the regional regulatory product strategies within assigned area
• Advising one or more EU regulatory leads on regulatory agency considerations in developing strategy.
• Ensuring support of GRTs and managing resources within assigned area
• Ensuring regional regulatory needs are well defined and implemented within assigned area.
Basic Qualifications/ Experience:
Bachelors degree, Masters or Doctorate preferable
In-depth experience of Regulatory Affairs including:
Demonstrable experience of defining and leading forward innovative regulatory strategies to advance novel therapies
-Providing a competitive advantage through strategy execution
In depth working experience with and knowledge of European Regulations
Experience of working with novel regulatory pathways/mechanisms would be advantageous.
Oncology experience is preferred but not essential