Senior Regulatory Specialist - Sponsor-Dedicated - FSP

To ensure that the documentation needed in order to obtain the corresponding authorizations by the Spanish Ethic Committees of Clinical Investigation – from now on, Ethic Committees) as well as Health Authorities (Spanish Agency for Medicines and Medical Devices – from now on AEMPS) and Autonomous Communities (if applicable) is prepared according to the current Spanish applicable legislation on Clinical Trials (CT) / post authorization studies (PAS) and according to the Sponsor policies.

• Acting as liaison/contact person with Corporate (Corporate Regulatory Affairs (CRA) and Clinical Teams) for all regulatory matters regarding CT / PAS (CTAs reception, reporting of incidences in documentation, communicating date of submission and trial authorization,…).
• Coordinating and supervising with each CT/PAS responsible and allocated monitoring teams in order to be able to duly prepare all necessary documentation, so that regulatory submission to the AEMPS, corresponding Ethic Committees and Autonomous Communities (if applicable) is ensured on a timely manner.
• Regulatory documentation management in order to process every CT/PAS application, modification and communication of closing, to the AEMPS, the corresponding Ethic Committee and Autonomous Communities (if applicable).
• Compilation of information relating Spanish and European Clinical Trials Legislation and distribution to the CSU team, in accordance with the Iberic Cluster Head, Support Services Manager (SSM) and the CSU Quality Leads (CSU-QL).
• Keeping constantly in touch with regulatory counterparts in order to follow-up all submitted documentation and obtain its authorization.
• Coordinating, being involved in the preparation and validating the responses to the questions presented from AEMPS, corresponding Ethic Committees and Autonomous Communities (if applicable).
• Notifying AEMPS, corresponding Ethic Committees and Autonomous Communities (if applicable) of all information regarding CT/PAS.
• To constantly keep in touch with the corresponding Ethic Committees, to follow-up all CT/PAS documentation submitted, in particular with the designated Ethic Committee (CEIm) to obtain a sole dictum on the CT.
• Managing and keeping up-to-date traceability tool (at CSU level –PANDORA- and at Corporate Level –Crystal TREK- that include information related to exchanged information with Ethic Committee, AEMPS and other authorities involved within trial period as well as tracking the regulatory milestones (approval dates).
• To authorize the first shipment of medication to the site; to supervise and validate the labelling of the study medication under according to current legislation requirements.
• To take part in external meetings related to Clinical Trials (Farmaindustria, AEFI -Spanish Associations of Pharmaceutical Industry-)
• Verify and co-ordinate the performance of clinical protocols and IMPD dossiers according to the local regulation.
• Participation in the local operational meeting (named COEC), as a Corporate Regulatory Affairs in the affiliate.
• Acting as liaison/contact person with Medical Direction Departments of Marketed Products for all regulatory matters regarding CT / PAS which CSU is involved.

Experience:

• Four years of experience in submission to LA and ECs.
• Fluent English and Spanish