REGULATORY AFFAIRS - GLOBAL PRODUCT LEAD

Social network you want to login/join with: Regulatory affairs - Global Product Lead, Varese Client: Pharma Point Location: Job Category: Other - EU work permit required: Yes Job Reference: 178731654248503705633712 Job Views: 2 Posted: 12.05.2025 Expiry Date: 26.06.2025 Job Description: Our client is a multinational pharmaceutical company with a portfolio that includes both innovative and established products. For the Italian affiliate, we are currently looking for: Regulatory affairs - Global Product Lead - New Products This role will spend about 25% of its time being a local Regulatory affiliate representative, acting as the primary point of contact for the Italian team and overseeing local activities. It will also support the existing portfolio, working closely with the LCM team, in-country regulatory partners, and Local Health Authorities. Key responsibilities include: Supporting and guiding the Business Development & Licensing Team in evaluating new projects primarily for the EU, UK, and Canada. Preparing global regulatory submission strategies, conducting dossier due diligence, and identifying timelines for new projects reviewed by senior management. Timely preparation and submission of regulatory applications for new pipeline products, including in-licensing and market registration. Reviewing and preparing CMC dossier sections. Communicating directly with regulatory authorities to facilitate productive dialogue on submissions and issues, including pre-submission steps and managing procedures. Providing timely and accurate responses to regulatory queries related to new products and activities. Managing relationships with new partners and their regulatory departments to ensure timely feedback. Reporting on regulatory progress and issues at project meetings and to senior management. Escalating risks or issues to remove barriers or inform of delays impacting approval timelines. Proposing improvements or alternative approaches for project success. Affiliate / In-country Local Italian Support: Acting as a liaison between Global Regulatory Affairs and the Italian affiliate, overseeing the portfolio and being the first contact for clarifications. Coordinating across global regulatory functions, considering country priorities, and facilitating local implementation of changes. Managing relationships and overseeing activities of local regulatory partners, providing support, interacting with authorities, and managing local databases and notifications. Minimum Requirements: 7 years of regulatory experience in pharmaceutical submissions. Experience interacting with EU regulatory authorities, including scientific advice and pre-submission meetings. International regulatory experience. Significant experience preparing Common Technical Dossiers, including CMC sections. Experience submitting National and European MAA (DCP, Centralized procedure). Excellent command of spoken and written English. J-18808-Ljbffr

Location: provincia-di-varese, IT

Posted Date: 6/16/2025