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Regulatory Affairs Project Leader Madrid Spain,
Posted on : 04 June 2017
- 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
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