• Regulatory lead for the assigned pharmaceutical product/projects (oncology), providing guidance to cross-functional teams to build and execute drug development plan, WW registration plan, strategy for major post approval changes • Under the role of Regulatory Lead, provide technical expertise in support of development of documentation for regulatory filing (M1, M2, M3, protocol and CSR revision)• Experience in ODD filing in EU, US and RoW• Interact with WW Regulatory Authorities leading the development of backgrounder material to support ScA meetings or Response to request for additional information• Provide Regulatory support for worldwide product launch• Provide regulatory inputs on promotional material• Large experience in Due diligence’s participation

• Regulatory Lead for the acne consumer business, overseeing projects from idealization to geographical roll-out and expansion (NPD/EPD - OTC, cosmetics, and MD)• Manage and mentor 2 Junior team members coordinating the activities to support MAA, LCM for the acne portfolio• Represent the RA function at the acne steering committee playing a key role in evaluating strategy, timelines, budget, and resources for ongoing acne program• Conducted risk analysis and created contingency plans for changes in development gates or project re-scoping• Explored local opportunities and changes in regulations to reclassify drugs from Rx to OTC• Lead interactions with competent authorities and coordinated activities for scientific advice meetings• Provided proactive analysis of potential regulatory changes or risks, along with resolution plans• Support the development of the marketing plan to prepare the product launch• Contribute to optimize internal processes

• RA representative for assigned projects/product mainly responsible to define and execute WW plan for re-classifying Rx-to-OTC• Provided regulatory inputs on CTD M2 and coordinated finalization of CTD M1 filing for assigned projects• Lead the activities to organize HA meeting to discuss about the Rx-to-OTC reclassification • Provide regulatory support to new product launch, including master artwork, promotional, and educational material development.• Managed global and regional submissions, including new marketing authorization applications, life-cycle management activities, and responses to health authority questions• Supported PSURs, RMPs, CCDS development and maintenance while coordinating activities for local implementation and PI maintenance• Maintain the proper regulatory affairs database

• Lead and coordinate the RA activities for the assigned therapeutic area (sore throat, fever&pain, cold&flu, well-being) at the Italian affiliate • Be the contact point for the Italian Medicine Agency (AIFA) or MOH for concerned medicinal product • Keep contact with category associations • Supervise, train and develop the assigned resource

• Manage the regulatory activities for assigned healthcare and personal care brands including OTC, SOP, cosmetics, MD, and biocides• Supported the development, evaluation, and approval of promotional and advertising materials• Implemented local requirements for medical devices (MDs)• Served as the contact point for regulatory topics during the acquisition of other companies, including due diligence, brands ownership transfer, stock transfers, and maintenance of quality management systems (QMS)• Maintain the proper regulatory database

• Support to the head of Regulatory for the compilation of the documentation requested for MMA and post-approval changes (MRP, National procedure)• Provide RA inputs for new cosmetics development and filing of cosmetic file

• Case management marketed and investigational drugs including WW reporting (oncology and anti-inflammatory) • Safety Database: Argus, ARISg, and RSGT

Contract manufacturing and manufacturing transfer