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Senior Director, Regulatory GRA International - United Kingdom  

Company managed [?] Still accepting applications
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Posted on : 01 May 2017

Project Description

Role overview: 
  • The purpose of the Senior Director, GRA-lnternational role is to provide leadership for all affiliate based international regulatory activities within the Emerging Market Business Unit (EMBU). 
  • The Senior Director is accountable for the support and performance of affiliate regulatory affairs, ensuring operational quality, efficiency and compliance are maintained in the execution of regulatory activities.  
  • He/she also represents Regulatory in third party negotiations and business opportunities, and supports alliance/CRO relationships.    
  • He/she develops and maintains collegial and mutually productive relationships with emerging market regulators and senior management at our company.


GRA-International 
  • Responsible for managing, training and development of P1 to P6 regulatory staff; this is accomplished by:Coaching of, and support for, individual regulatory staff career development with actionable developmental plans for all direct reports
  • Planning staff development programs
  • Leadership in change initiatives and staff motivation
  • Proactive staff recruitment, development and retention
  • Promoting corporate integrity
  • Propose, review and implement projects to improve efficiency/productivity/capabilities of GRA for International markets
  • Facilitate resolution of key regulatory issues arising in affiliates
  • Active participation at Regulatory Strategy Committee
  • Deputize as requested for the VP International Regulatory Affairs on projects or on product or non-product related issues


Business Units
  • Ensure that GRA objectives are met by working with the MDU and Business units effectively to
  • Comply with all applicable guidelines and internal quality systems
  • Deliver on time submissions/approvals of emerging markets product license applications
  • Provide a key regulatory management contact for the EMBU
  • Provide timely communication updates to management and other internal stakeholders
  • Provide authoritative, up-to date expertise on all aspects of emerging markets registration procedures
  • Anticipate impact of new guidelines, initiate changes within corporate headquarters in response to changing environment
  • Drive, and as necessary lead appropriate interactions and represent our company at key meetings with agencies


Business
  • Bring regulatory drivers and perspectives to the EMBU
  • influence the external environment (regulatory agencies/ industry associations) in favor of the company positions
  • Participate in EMBU meetings (commercial managers, medical directors, business development director) to ensure that regulatory needs and issues are taken into account
  • Advise senior management on the regulatory consequences of proposed regulatory action   


Basic Requirements:  
Education and Experience
  • Uses strong interpersonal skills in a matrix organization to achieve objectives
  • Builds and extends relationships with regulators and internal and external partners on key decisions
  • Able to guide teams through all stages of development with a proactive and analytical approach
  • Influences strategic direction of the function
  • Technical Knowledge/Expertise:Has and applies wide knowledge and understanding of drug development
  • Contributor to regulatory change via track associations
  • At least 10 years' experience in regulatory affairs (authority or industry) and/or extensive experience in a research based drug development role with regulatory affairs exposure
  • Problem Solving: Evaluates and resolves highly complex or unusual business and organizational problems
  • Resource Management: Ability to allocate resources to meet performance requirements
  • Decision Making: Makes decisions guided by functional strategies and priorities that impact regional or functional results
  • Accountability and Scope: Accountable for all emerging market regulatory activities to meet the business needs
  • Strategic Planning: Contributes to and executes aspects of the functional plan (International Regulatory Affairs) with a time horizon of up to 3 years