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Regulatory Affairs Project Leader Madrid Spain,  

Posted on : 04 June 2017

Project Description

6/1/2017 Global Responsibility: Global responsibility as an RA Project Leader for designated projects Specific Responsibilities: Being the RA Project Leader and taking responsibility for all technical and scientific aspects of a biosimilar 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 mAxience 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


Madrid Spain

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