Amgen Extended Europe Regulatory Lead in Uxbridge, United Kingdom

Title (Role) Extended Europe Regulatory Lead (EERL), Manager / Sr. Manager

Organization Europe Regional Regulatory

Team Regional Regulatory

Group Purpose

Facilitate patient access to Amgen products in Extended European countries (to include Israel/Russia/Balkans/Commonwealth of Independent States (CIS) countries) through executing on the Extended European filing plan; providing strategic regional regulatory guidance, in collaboration with the local offices, on regional regulatory mechanisms to optimize product development and approvals; aligning with key cross-functional partners; integrating into Amgen's commercialization process as appropriate, and continuously improving our processes and developing our talent.

Job Summary

  • To ensure that Amgen acquires and maintains all the required licenses in the Extended European Region.

  • To ensure regulatory compliance, with a focus on patient safety.

  • As requested, this role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff (dependent on grade)

This role is:

  • Based in the European Headquarters or Extended Europe, with interaction primarily with European Regulatory Leads (EURL) and Regulatory Leads in Affiliates (LRR)

This role reports to:

  • Senior Manager, Director or Executive Director in EU Regulatory Affairs

This role is accountable for:

  • Developing and Executing the approved regional strategy for assigned programs

This role is responsible for:

  • Advising the Global Regulatory Team (GRT) via the EURL on regional considerations in developing strategy (Extended Europe RL is an ad hoc GRT member)

  • Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders

May participate as a member of:

  • Regional Teams and Global Teams as an ad hoc member

Key Activities

Strategy and Execution

  • Plans and manages regulatory submissions (e.g. Marketing Authorization Applications (MAA) and Life Cycle Management (LCM) submissions) for products within Amgen's portfolio in collaboration with the relevant teams and functions and in compliance with global and regional filing plans and local regulatory requirements

  • Develops, in association with the local team, product related regulatory strategies, considering precedence, risk management and contingency planning

  • Thoughtfully reviews pertinent Extended Europe processes and refines as necessary to ensure continuous improvement and streamlining

  • Inputs to the development of regional regulatory documents and meetings in accordance with GRT strategy via the EURL

  • Works with LRR and EURL to optimise submission strategy taking into account local legislation and guidance

  • Supports development of the regional product label based on commercial objectives, the available and expected scientific data, regulatory guidance and precedent

  • Supports regional label negotiation activities

Project Management

  • Responsible for the coordination and planning of all product filings for Regulatory Affairs across all Extended Europe markets

  • Tracking and submission planning for all Extended Europe markets

Key Activities

  • Coordinates MAAs, LCM submissions and Responses to Questions

  • Communicates regulatory strategies as appropriate

  • Estimates the likelihood of regulatory success based on proposed strategies and discuss with the EURL

  • Develops predictions for expectations and risks associated with outcomes by regulatory agencies in collaboration with LRR

  • Ensure regulatory compliance for product (e.g. IMR, PMCs, and other agency commitments)

  • Share regulatory information and implications with EURLs on an ongoing basis and provide advice on regional considerations

  • Partners with regional management and peers to ensure consistency in procedures and Agency interactions

  • Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products and evaluates and communicates the impact

Management

  • Provides managerial leadership & direction to assigned team allowing appropriate prioritization of resources to achieve goals.

Knowledge and Skills

Knowledge and Skills

  • Regulatory principles

  • Working with policies, procedures and SOP's

  • Knowledge of national legislation and regulations relating to medicinal products

  • Awareness of the registration procedures in region for MA, post approval changes, extensions and renewals.

  • Knowledge of drug development

Scientific / Technical Excellence

  • Strong and collaborative team work

  • Excellent communication skills - both oral and written

  • Ability to understand and communicate scientific/clinical information

  • Ability to anticipate and prevent potential issues

  • Knowledge of and experience in regional regulatory environment in relevant product area and development stage

  • Understanding of regulatory activities and their touch points

  • Ability to resolve conflicts and develop a course of action leading to a beneficial outcome

  • Cultural awareness and sensitivity to achieve results across both regional, country and International borders.

Education and Experience Requirements

Basic requirements:

  • Scientific Degree and demonstrated experience in a similar role

  • Regulatory principles

  • Working with policies, procedures and SOP's

  • Knowledge of legislation and regulations relating to medicinal products

  • Awareness of the registration procedures in region for MA, post approval changes, extensions and renewals.

  • Knowledge of drug development

  • Knowledge of and experience in regional regulatory environment

  • Team work

  • Communication skills - both oral and written

  • Ability to understand and communicate scientific/clinical information

  • Ability to anticipate and prevent potential issues

  • Ability to resolve conflicts and develop a course of action leading to a beneficial outcome

Preferred Qualifications:

  • MSc/PhD in Life Sciences

  • Experience interacting with regulatory agencies

  • In-depth regulatory experience related to Extended Europe Region;

  • Knowledge of Extended EU countries legislation and regulations relating to medicinal products

  • Cultural awareness and sensitivity to achieve results across both regional country and International borders.

Amgen is an equal opportunities employer.

HJE2018