Requirements: English
Company: JR Italy
Region: Lodi , Lombardy
The provided job description is fairly detailed but could benefit from improved formatting and clarity. I will organize the responsibilities and requirements into clearer sections, use consistent HTML tags for better readability, and remove any irrelevant content. Here''s the refined version:Regulatory Affairs - Global Product Lead, LodiClient: Pharma PointLocation: Lodi, ItalyJob Category: OtherEU Work Permit Required: YesJob Reference: 787187599637741568033712Job Views: 2Posted: 26.05.2025Expiry Date: 10.07.2025Job DescriptionOur client is a multinational pharmaceutical company with a portfolio that includes both innovative and established products.We are currently seeking a Regulatory Affairs - Global Product Lead - New Products for the Italian affiliate. This role will dedicate approximately 25% of its time to acting as the local Regulatory affiliate representative, serving as the primary contact for the Italian team and overseeing local activities. The role also involves supporting the existing product portfolio, working closely with the Lifecycle Management (LCM) team, in-country regulatory partners, and Local Health Authorities.Key ResponsibilitiesNew Submission / In-Licensing SupportProvide support and guidance to the Business Development & Licensing team when evaluating new projects, primarily for EU, UK, and Canada.Develop regulatory submission strategies globally, conduct dossier due diligence, and identify timelines for new projects reviewed and approved by senior management.Prepare and submit regulatory applications for new pipeline products, including in-licensing, product developments, and registration of existing products into new markets.Review and prepare CMC dossier sections.Communicate directly with regulatory authorities to facilitate productive dialogue, including pre-submission steps and management of regulatory procedures (Centralized or DCP).Respond timely and accurately to regulatory queries related to new product activities.Manage relationships with new partners regulatory departments to ensure timely feedback.Report on regulatory progress and issues at project team meetings and to senior management.Escalate risks or issues to remove barriers or inform of delays impacting approval timelines.Propose improvements or alternative approaches for project deliverables.Affiliate / In-country Local Italian SupportAct as a liaison between Global Regulatory Affairs and the local Italian affiliate, overseeing the Italian product portfolio and serving as the first point of contact for clarifications.Coordinate across global regulatory functions, considering country priorities, and facilitate implementation of changes locally.Manage relationships with local regulatory partners, provide strategic support, interact with local Health Authorities, and oversee local activities such as database updates and stock notifications.Requirements7+ years of regulatory experience in pharmaceutical product submissions.Experience interacting with EU regulatory authorities, including scientific advice and pre-submission meetings.International regulatory experience.Strong understanding of preparing Common Technical Dossiers, including CMC sections.Experience submitting National and European Marketing Authorization Applications (DCP, Centralized procedure).Excellent command of both spoken and written English.#J-18808-Ljbffr