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Director, EU Regulatory Affairs Uxbridge United Kingdom,  

Amgen (company)


Posted on : 07 May 2017

Project Description

Group Purpose
  • Facilitate patient access to company products in EU and Extended EU countries through executing on our filing plan; providing strategic regional regulatory guidance on regional regulatory mechanisms to optimize product development and approvals; aligning with key cross-functional partners; integrating into company s commercialization process, and continuously improving our processes and developing our talent.


Job Summary
The purpose of this role is:
  • To provide management and leadership by advising on the development and execution  of regulatory strategy and plans for regulatory agency interactions within his or her assigned area
  • To ensure appropriate regulatory input is provided into regulatory plans
  • To provide oversight of a number of European Regulatory Leads in technical procedures of European regulatory activities
  • To support EU Regulatory Leads in EU regulatory agency interactions
  • To facilitate patient access to company 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 EU regulatory activities


Responsible for:
  • Execution of the EU regulatory product strategies within assigned area
  • Advising the EU regulatory leads on regulatory agency considerations in developing strategy.
  • Ensuring support of GRTs and managing resources within assigned area
  • Ensuring EU regulatory needs are well defined and implemented within assigned area.



Key Activities
Strategy and Execution
  • Advise the EU regulatory lead on the execution of regional regulatory strategy and plan within assigned area
  • Advise EU regulatory lead in the development of regional regulatory product strategies within assigned area, including precedence, risk management and contingency planning
  • Monitor, assess and communicate to staff and management impact of relevant regulations, guidances, and current regulatory environment
  • May serve as EU regulatory lead for one or more programs.  In this capacity, the role will develop regional regulatory strategies, ensure all regulatory activities are in alignment with the strategic direction of the GRT, and provide review and approval of regional regulatory strategies and submissions.



Management
  • Provides managerial leadership & direction to  the regional regulatory team within assigned area allowing appropriate prioritization of resources to achieve goals.
  • Represent region for regulatory in governance forums, as assigned. 
  • Complete resource planning to ensure resources are available and assigned to Global Regulatory Teams (GRTs)
  • Engage GRLs regularly in obtaining feedback on regional regulatory lead performance
  • Recruit and retain talented regulatory affairs professionals. Provide coaching, mentoring, and development of staff
  • Ensure staff are compliant with company corporate and departmental training
  • Disseminate relevant information to teams as appropriate
  • Provide input to GRAAS goals development .
  • Accountable for delivery against goals  assigned to group.
  • Provide input to budget and headcount planning
  • Participate in  or lead regional regulatory process improvements, initiatives and training  and  track metrics for team deliverables.
  • Develop functional expertise of regional regulatory leads to support evaluation of regulatory success based on proposed strategies
  • Develop the ability of staff to accurately predict outcomes of regulatory meetings 
  • Educate regional regulatory leads on the evolving regulatory agency environment and how to anticipate that environment in regulatory strategy development



Collaboration
  • Exchange regulatory information with other regulatory colleagues on an ongoing basis and provide advice on regional regulatory considerations (e.g. prior to relevant management review committees and governance boards).
  • Communicate and ensure alignment of functional and cross-functional goals and objectives.


Health Authority Interactions
  • Advise regional regulatory leads on technical procedures related to regional regulatory interactions.  
  • Oversee effective agency interactions in line with global regulatory strategy
  • Ensure regional regulatory product compliance (e.g. PMCs, inspection readiness, pediatric and other agency commitments) within assigned area


External
  • In collaboration with GRAAS Policy leads, advocate for company/GRAAS by building relationships with key external stakeholders (e.g., regulatory agency officials, trade associations and professional bodies), as assigned
  • Work externally to influence the regulatory environment in line with company  policy priorities, as assigned


Knowledge and Skills
  • Ability to lead teams
  • Strong communication skills - both oral and written. 
  • Ability to communicate effectively with management and cross-functionally
  • Ability to understand and communicate scientific/clinical information
  • Understanding of regulatory activities and how they affect projects and processes
  • Ability to set organizational direction & champion change and continuous improvement
  • Ability to anticipate and mitigate against future strategic issues & uncertainties
  • 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.


Competencies:
  • Leadership skills
  • Conflict management
  • Directing others
  • Managing diversity
  • Listening
  • Managing and measuring work
  • Building effective teams



Education & Experience (Preferred)
  • Bachelor s degree and in-depth regulatory experience related to the region.
  • Knowledge of EU countries legislation and regulations relating to medicinal products
  • Knowledge of drug development Scientific / Technical Excellence
  • Team work
  • Communication skills both oral and written
  • Ability to understand and communicate scientific/clinical information
  • Cultural awareness and sensitivity to achieve results across both regional country and International borders
  • Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resource

Locations

United Kingdom Uxbridge

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