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Director, EU Regulatory Affairs Uxbridge United Kingdom,  


Posted on : 07 May 2017

Project Description

Title (Role)DirectorOrganizationEurope Regional RegulatoryTeamRegional RegulatoryGroup PurposeFacilitate patient access to Amgen 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 Amgen s commercialization process, and continuously improving our processes and developing our talent.Job SummaryThe 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 areaTo ensure appropriate regulatory input is provided into regulatory plansTo provide oversight of a number of European Regulatory Leads in technical procedures of European regulatory activitiesTo support EU Regulatory Leads in EU regulatory agency interactionsTo facilitate patient access to Amgen products by ensuring adequate resources for regulatory filing plans within assigned areaTo manage forums for sharing of best practices and lessons learned related to EU regulatory activitiesResponsible for:Execution of the EU regulatory product strategies within assigned areaAdvising the EU regulatory leads on regulatory agency considerations in developing strategy.Ensuring support of GRTs and managing resources within assigned areaEnsuring EU regulatory needs are well defined and implemented within assigned area.Key ActivitiesStrategy and ExecutionAdvise the EU regulatory lead on the execution of regional regulatory strategy and plan within assigned areaAdvise EU regulatory lead in the development of regional regulatory product strategies within assigned area, including precedence, risk management and contingency planningMonitor, assess and communicate to staff and management impact of relevant regulations, guidances, and current regulatory environmentMay 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.ManagementProvides 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 performanceRecruit and retain talented regulatory affairs professionals. Provide coaching, mentoring, and development of staffEnsure staff are compliant with Amgen corporate and departmental trainingDisseminate relevant information to teams as appropriateProvide input to GRAAS goals development .Accountable for delivery against goals assigned to group.Provide input to budget and headcount planningParticipate 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 strategiesDevelop 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 developmentCollaborationExchange 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 InteractionsAdvise regional regulatory leads on technical procedures related to regional regulatory interactions. Oversee effective agency interactions in line with global regulatory strategyEnsure regional regulatory product compliance (e.g. PMCs, inspection readiness, pediatric and other agency commitments) within assigned area ExternalIn collaboration with GRAAS Policy leads, advocate for Amgen/GRAAS by building relationships with key external stakeholders (e.g., regulatory agency officials, trade associations and professional bodies), as assignedWork externally to influence the regulatory environment in line with Amgen policy priorities, as assignedKnowledge and SkillsAbility to lead teamsStrong communication skills - both oral and written. Ability to communicate effectively with management and cross-functionallyAbility to understand and communicate scientific/clinical informationUnderstanding of regulatory activities and how they affect projects and processesAbility to set organizational direction & champion change and continuous improvementAbility to anticipate and mitigate against future strategic issues & uncertaintiesAbility to resolve conflicts and develop a course of action leading to a beneficial outcomeCultural awareness and sensitivity to achieve results across both regional country and International borders.Competencies:Leadership skillsConflict managementDirecting othersManaging diversityListeningManaging and measuring workBuilding effective teamsEducation & Experience (Preferred)Bachelor s degree and in-depth regulatory experience related to the region.Knowledge of EU countries legislation and regulations relating to medicinal productsKnowledge of drug development Scientific / Technical ExcellenceTeam workCommunication skills both oral and writtenAbility to understand and communicate scientific/clinical informationCultural awareness and sensitivity to achieve results across both regional country and International bordersManagerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resourcesAmgen is an equal opportunities employer.HJE2017

Locations

United Kingdom Uxbridge

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