Spécialiste Affaires Réglementaires - Sénior H/F Bayer

--- Regulatory Affairs Specialist Senior Position: Major Tasks Ensure by delegation of the Responsible Pharmacist the pharmaceutical operations described in the delegation in force in reference to the article R.5124 36 of the Public Health Code Ensure local regulatory compliance with the Bayer procedures (SOP) and in line with the French legislation by: * Taking in charge promotional activities for the assigned range of products : by reviewing the promotional campaign along the process and ensuring regulatory compliance to avoid rejections from the health authorities by coordinating submission of the dossiers to the Health Authorities and following their approvals/rejections by signing off on ready for press approval with Product Managers by advising Business Units (BUs) on regulatory aspects that are importance for their activities by taking part actively in handling potential issues with the French Health authorities (ANSM) and/or Bayer competitors by timely updating the legally required texts on promotional documents by taking part in managing the stock of promotional material (orders to destroy, decision not to renew) in cooperation with the Departments/BU involved by actively participate in context of Audit/Sales certifications, being referent and represent RA team for promotion activities. * Ensuring timely, with high quality and properly documented, submission of: labeling changes based on the CCDS according to Bayer procedures quality related changes according to the agreed timelines PSUR/PBRERs and DSURs applications for new Marketing Authorization, line extensions and new indications, or any submissions linked to Life Cycle Management activities (LCM) renewals in order to keep Marketing Authorizations valid in the country high quality translations of Product Information for CP approved products /MRP/DCP other documents and information as required * Ensuring timely implementation of approved labeling and CMC changes into the packaging materials according to SOP and the local legislation. * Supporting Clinical Trials activities (submission, approval and LCM) to facilitate a timely start in France in line with local regulations, in the framework of the global product development strategy. * Ensuring regular monitoring of the submission status with the authorities, contributing to the preparation of answers to deficiency letters and other Authority requests in cooperation with GRS or EPM, documenting all relevant contacts in a factual manner, checking of incoming documents and initiating their correction, if needed. * Timely update of internal, external databases, internet websites, other sites managed by Bayer and document management systems (like BRAVE, Sharedoc, local compendia, etc.), and by providing relevant information on RA milestones to GRA and other functions on the local level (Medical, Pharmacovigilance, Product Supply, Business, Communication, Market Access, etc.). * Archiving of all documents and correspondence submitted to and received from the Authority according to the Global SOP and locally agreed processes. * Ensuring RA support on different projects by: participating to the review of the educational materials, by submitting it to the Health authorities and by ensuring its availability and follow up in d --- --- --- Période de soumission des candidatures le code de référence: 851169 Division: Pharmaceutique Lieu: France : Nord : Lille Fonction: Affaires réglementaires Niveau du poste: VS 1.2 Type d'emploi: Permanent --- Contact Us Addresse Téléphone E-Mail 2920 Matheson Blvd. East, Mississauga, Ontario, L4W 5R6 1-855-623-8178 ****@****.**