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Manager, Regulatory Affairs Immunology - United Kingdom  

Company managed [?] Still accepting applications
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Posted on : 26 December 2016

Project Description

Travel: Yes, 10 % of the Time

  • Contributes to the initial development, execution & delivery of EU regulatory strategy for projects assigned. 
  • Responsible for the building of regulatory dossiers to achieve timely regulatory approvals & maintenance of the existing product portfolio. 
  • Liaises with Regulatory Strategy Leader, Regulatory Affairs (RA) Projects Team management & with other internal/external stakeholders.     

Core Responsibilities  
  •  Contributes to the execution of development & submission strategies in EU for projects assigned. 
  •  Works with Regulatory Strategy Leader & Regulatory Projects Team leadership to ensure that development programs & product life-cycle plans are aligned with regulatory requirements. 
  •  Contributes to the assessment of the pros, cons & risks associated with regional strategic options for projects assigned. 
  •  Contributes ideas to the design of innovative regulatory pathways. 
  •  Supports Regulatory Projects Team Leadership on development of regulatory tactics to be communicated to internal stakeholders, e.g. Global Project Team as requested 
  •  May interface between global & regional headquarters to ensure both parties are kept updated on regulatory progress & operational issues & may participate in global regulatory therapeutic area (TA) team. 
  •  May develop or contribute to the development of high quality regulatory dossiers (e.g., scientific advice requests, orphan medicinal product designation applications, MAAs & variations), ensuring compliance with regulatory requirements. 
  •  Develops content of regulatory documents working with other functions as necessary & contributes to the review of documents before submission. 
  •  Reviews draft protocols, acts as Regulatory Project Team representative in clinical study teams & liaises with the Clinical Trials Applications (CTA) group.  
  •  May act as subject matter expert on designated studies in the event of a Health Authority inspection 
  •  Responsible for the delivery of Content Plans to allow publishing & timely dossier submission. 
  •  Responsible for tracking & communicating regulatory activities within RA & responsible for accurate submission plans in eQRMS 
  •  Identifies & communicates to manager, any emerging issues that may impact company’s business.  
  •  May participate in interactions with Regulatory Authorities, including agency meetings. 
  •  Supports the optimisation of product information achieved through negotiation with internal stakeholders & Regulatory Authorities. 
  •  Supports activities to ensure that our company  fulfills Health Authority commitments. 
  •  May participate in regional launch team 
  •  May be responsible for the regulatory review & approval of commercial advertising & promotional literature 
  •  Highlights resource constraints through discussion with manager. 
  •  Identifies any learning or best practice & communicates to manager. 
  •  Responsible for maintaining knowledge of current EU regulatory guidance & procedures 
  •  May participate in cross-functional initiatives. 
  •  International travel may be necessary. 

Key Requirements/Knowledge
  •  Bachelor’s degree in scientific discipline or equivalent required.  
  •  Experience in EU Regulatory Affairs & recent experience of EU Centralized Procedure required. 
  •  Good understanding of current regulatory requirements essential 
  •  Good understanding of CTD modules; non-clinical, CMC, Clinical 
  •  Thorough understanding of core processes of drug discovery, development, manufacturing & marketing required. 
  •  Developing understanding of TA for projects assigned 
  •  Experience in Inflammation/ Immunology preferred 
  •  Able to contribute to Ph III protocols & clinical development plans. 

  •  Takes initiative for professional development 
  •  Seeks opportunities to learn from others 
  •  Effective project manager. Prioritizes tasks appropriately. 
  • Able to & coordinate the delivery of multiple projects 
  •  Ability to lead routine regulatory submissions.
  •  Leads activities for assigned projects 
  •  Demonstrates appropriate decision making 
  •  Displays a willingness to challenge the status quo & take risks  & acknowledges others who take the initiative to try new approaches even if the results are not perfect 
  •  Can identify when to escalate issues to line management & knows when to seek advice. 
  •  Communicates complex ideas effectively across a culturally diverse environment 
  •  Communicates effectively  with Regulatory Authorities when tasks have been delegated 
  •  Obtains alignment through effective communication 
  •  Ability to influence internal stakeholders  
  •  Exhibits consistent professional behaviours