REGULATORY INFORMATION COORDINATOR - M/F

Description :

Within the Regulatory Affairs department, reporting directly to the Regulatory Affairs Manager (GRA Manager), the Regulatory Information Coordinator is responsible for the management of regulatory information (RIM) with the associated procedures and tools.

In this capacity, he/she is the guarantor of the compliance of regulatory information entered into the systems for the entire Mayoly drug portfolio worldwide. He/she is the business administrator of the OneRIM (Veeva Vault) tool and is in charge of its maintenance in partnership with the publisher and the Mayoly IT department.

• Ensure the management/administration of regulatory information: the data and documents entered into OneRIM must reflect reality for the entire Mayoly portfolio worldwide. Creation of Regulatory objectives, integration of documents from functions that do not have access to OneRIM (e.g. PSURs), entry of data from subsidiaries that do not have access to OneRIM
• Responsible for Article 57 (xEVMPD): ensure the maintenance of data updates in xEVMPD format
• Be the IDMP referent for Mayoly: implementation of current standards, advisory role to the Regulatory Affairs Manager, team training
• Update and enforce the procedures governing the use of OneRIM. Contribute to the update of regulatory affairs procedures involving the use of OneRIM
• Ensure data quality and data integrity within the framework of Mayoly's Data Governance initiatives: definition and monitoring of KPIs, training / support for operational staff
• OneRIM: business administrator for the GRA department, superuser. Supervises the accessibility of OneRIM and the tools used to ensure regulatory information management. Ensures communication regarding any change impacting OneRIM users.
• Act as a facilitator between GRA and other functions, for example coordinating publishing with the service provider
• Ensure regulatory monitoring related to the RIM field (IDMP/SPOR, xEVMPD, databases, etc.).

Profile sought:

EDUCATION / DEGREES: Master's degree (Bac+4/5) in Pharmacy, Regulatory Affairs, Life Sciences or equivalent. Initial experience in Regulatory Affairs is sought, ideally in an international environment. Exposure to regulatory information management activities, regulatory databases, or Regulatory CMC topics would be a real asset.

YOUR SKILLS / EXPERTISE: You possess a good understanding of regulatory databases and RIM systems, ideally acquired on Veeva Vault. You are comfortable with topics related to regulatory data quality and governance and have knowledge of IDMP standards as well as Article 57 (xEVMPD). You enjoy highly digitalized environments and data management tools.

YOUR SOFT SKILLS: Rigorous, organized, and possessing good analytical skills, you enjoy working cross-functionally with various stakeholders. Your sense of service, your pedagogical skills, and your interpersonal skills allow you to support teams and promote best practices. You are recognized for your ability to coordinate complex subjects and to evolve in an international context.

LANGUAGES: Your English is professional (indispensable) in order to manage international partners.

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