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Regulatory Affairs Project Leader Madrid 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

Locations

Madrid Spain

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