Director Regulatory Affairs Europe

Amgen ,
Uxbridge, Greater London
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**Director Regulatory Affairs Europe** As we are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules - and we are looking for top talent to ensure these molecules become medicines and realize their potential for helping patients. 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. The role will be responsible for providing strategic input into the filing plans for the EU as well as Russia, Israel, the Baltic States and Switzerland. Director Regulatory Affairs Overview: You will have the responsibility for providing regulatory leadership, technical expertise including strategic guidance, and execution for the development, registration, and lifecycle management of a portfolio of products. As an experienced Director, you will be required to define innovative regulatory strategies for accelerating the development of the oncology portfolio, challenging regulatory precedence and demonstration of calculated risk taking, as well as interpreting the impact of the external regulatory environment and precedence in advancing Amgen's portfolio. Role summary: + 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 lead 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 You will be responsible for: + 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. Required skills and experience: + Bachelors degree, Masters or Doctorate preferable + In-depth experience of Regulatory Affairs including: - Proven 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 Location: Uxbridge or Cambridge Today, Amgen is advancing the largest early Oncology pipeline in our history spanning several innovative technology platforms - Bispecific T Cell Engagers (BiTEs), CAR Ts, Bispecific Antibodies, Oncolytic Viruses, Neoantigen Vaccine and Small Molecules - across many targets and more than a dozen tumor types. Many of these innovative modalities/technologies are not only firsts for Amgen, but also for the entire biotechnology field. By joining our team, you will help us seize the opportunities that come with paving new roads - roads that ultimately lead to directly serving oncology patients. We are advancing more than a dozen BiTE programs, across multiple different targets including in hematologic malignancies and solid tumors. We are on a constant search to extend the modalities or identify complimentary platforms that could enhance our ability to deliver breakthroughs. Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. We equip all our staff members to live well-rounded, healthy lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join Us If you're seeking a career where you can truly make a d

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