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Regulatory Affairs Project Leader - Spain  

MABxience (company)


Posted on : 04 June 2017

Project Description

Specific Responsibilities: 
  • Being the RA Project Leader and taking responsibility for all technical and scientific aspects of a bio similar project primarily but possibly other projects as determined by the Head of Regulatory Affairs. This includes the building/preparation of the registration dossiers (both initial and updates/variations) and ensuring the scientific content meets regulatory agency requirements/expectations to minimize questions from the Agencies. 
  • Being the technical/scientific/strategy expert or knowledgeable person within the RA function for the project(s) in question. 
  • Responsibility for preparation and maintenance of RA reports relating to the project eg. input to the monthly RA status report for senior management. 
  • Responsibility for recording of the tracking of registration status/activities in appropriate databases eg. product submission and approval status tracking. 
  • Responsibility for the preparation of presentations relating to RA activities for the project  for  
  • Evaluating Change Control requests from Manufacturing/Quality and inputting the regulatory data/document requirements to support changes requiring regulatory submission and/or approval  
  • Preparation and maintenance of RA SOPs as defined by the Head of Regulatory Affairs and participation in regulatory agency audits/inspections 
  • Reviewing and evaluating various technical and licensing documents from a RA perspective eg. study protocols, study reports, licensing agreements, technical agreements 
  • Inputting to the proposed product development plan to ensure that the data generated will be sufficient for clinical trial and marketing authorization applications and complies with relevant regulatory guidelines/requirements 
  • Responsibility for RA support for the projects including  
  • development & maintenance of the regulatory strategy 
  • input to the Project Team and decisions on product development 
  • Representing the RA department in internal and external meetings 
  • Preparation of registration documentation eg. clinical trial applications/IMPDS, IND´s, NDAs, Japan registration documents, variation dossiers 
  • Management and coordination of scientific advice activities for the project 
  • Management of any external RA consultants engaged to work on aspects of the project 
  • Interaction and liaison with the partner companies and regulatory agencies in terms of the submission, processing and maintenance of all registration applications in defined countries/regions. Preparation of responses to Partner Company and Regulatory Agency questions and requests for further information  
  • Interaction with and close working association/relationship with other functions within company especially:  
    • R&D 
    • Operations/manufacturing 
    • Quality  
    • Clinical 
    • Business Development/Commercial 
    • Project Management   
  • Interaction with CROs (clinical and/or regulatory) in terms of regulatory activities undertaken by the CRO on company  behalf 
  • Direction and supervision of other RA staff in their regulatory affairs activities on the defined project eg Partner Liaison RA staff and other junior staff working on the project. 
  • Representing the RA department in internal and external meetings 
  • Participating in due diligence and licencing activities from an RA perspective as determined by Commercial/Business Development 
  • Acting as a mentor to other RA staff 
  • Undertaking defined regulatory intelligence gathering, interpretation and dissemination activities eg. monitoring changes in the regulatory legislation and guidelines and assessing their impact on activities within the company  and communication of such matters within the company.
  • When requested, to be the deputy for the Head of Department during periods of absence, etc. 
  • Providing input to the RA budget for the relevant projects.