Alternance - Chargé d'Affaires Technico-Règlementaires Cmc Dermatologie H/F Bayer

Détail du poste

Position : Major Tasks Position : Major Tasks All assignments and tasks must BE carried out in compliance with the IT security regulations in effect within BCC and Bayer. 1. Creation and/or update of technical files and pharmaceutical evaluations. For renewals, changes in registration file format and launches in new countries, make sure the technical file is pertinent and compliant : Ensure compliance with regulations in force for each raw material (ex. BSE/TSE) and the finished product - Check that the file is coherent and make any necessary corrections or have them made - Make sure that IT complies with regulatory constraints and internal procedures for quality. Should any shortcoming BE identified in the file, collect the missing data or make sure IT is generated by the manufacturing sites, raw material coordinator, ITC or sub-contractors.
- Make sure the file is compliant (regulatory compliance) with practices of the manufacturing site. Should a deviation BE identified, have corrections made and request that any necessary changes BE made at the manufacturing sites.
- Integrate additional data such as stability data and industrial validation data into the file. Compile or supervise thesubcontracting of the files or QOS. Inspect the dispatch of files to the regulatory group in Basel. 2. Manage change requests Evaluate change requests from the technical and regulatory point of view and make a recommendation for data to BE generated to approve the change. Draft the parts of the technical file to BE modified, or have them drafted. Check the regulatory documents from the manufacturing sites. Compile the variation pack needed for any change, including the table listing the variations and control its distribution to the regulatory group in Basel. 3. Respond to technical and regulatory questions from the health authorities concerning the technical files or variations submitted, or to technicaland regulatory questions from internal customers (Basel regulatory group and/or regulatory affiliates) Draft technical responses to received questions by the defined deadlines. For certain complex questions, write and validate the content of responses with the GIDC area experts, manufacturing sites, regulatory and quality groups in Basel, or the Regulatory Affiliates. 4. Participate in the life of the department : Keep yourself informed of regulations governing technical files, for product ranges under your responsibility and for countries in which the products are registered. For a specific field of activity, participate in technical and regulatory monitoring by collecting, analyzing and distributing new regulatory information to those affected. Participate in working groups within GIDC or R&D; groups, as a technical and regulatory expert. Draft and implement procedures for the department's activity. Create links with the European Headquarters in Basel, other technical and regulatory BCC teams, the manufacturing sites and Regulatory Affiliates in the main countries concerned, to ensure efficient exchanges of information and optimal collaboration. 5. Understand the procedures and safetynotices in effect on the site and in your sector in order to : Share, apply and ensure the correct application of safety instructions, regulations and procedures. Inform your