Interim Executive Director Regulatory Affairs

With nearly 40 years of experience, she excels in developing and executing regulatory strategies for pharmaceutical products across Europe, ensuring compliance and successful market authorization

Proven leader in managing multinational teams, she has successfully registered over 70 products through various EU procedures, including centralized, mutual recognition, and decentralized processes

Expert in regulatory affairs, she has led the regulatory transition during major corporate changes, including mergers and acquisitions, ensuring seamless integration and compliance

Holds a specialization in Industrial Pharmacy and is a qualified EU Qualified Person, with a strong background in pharmacovigilance and regulatory compliance for medical devices and pharmaceuticals

Led a multinational/multicultural 9-people Regional Team with geographic responsibility of EU countries and ex-EU countries (United Kingdom, Switzerland, and Balkans) and successfully managed 11 products registered through Centralised Procedure and >60 products and biosimilars registered through Mutual Recognition/Decentralised Procedures

Stand-up the regulatory organization and processes of the new Company after spin-off

Developed and executed EU product regulatory strategies to optimize labelling contents for initial registrations; life cycle maintenance, of already registered products e.g., new indications, safety label updates, CMC changes. Responsible for compliance with regulations and internal procedures/policies in the EU region for the portfolio in scope. Interactions with subsidiaries and/or Regulatory Agencies

Oversaw Clinical Trial applications (CTA) according to EU Regulation 536/2014 through CTIS portal; PIP applications; obtainment of National Agencies and EMA Scientific Advice for label expansion; EMA Business Pipeline meeting

Obtained CE mark for class I and II Medical Devices and Combination products, in compliance with the EU Regulation 745/2017

Successfully led 4 direct reports (in a 13-people Team) also through promotion lifecycle as a result of professional development plans

Successfully obtained and maintained Marketing Authorizations in compliance with Local & European regulations (60 brands’ portfolio); medical devices, food supplement, cosmetic

Interactions with Italian Health Authorities: EMA Pre-submission meetings as AIFA Rapporteur of a Centralised procedure of an innovative MAB for onco-therapy

Regulatory support to: spinoff/standing up (2020); dissolution/integration (2018); acquisition and integration (2016); manufacturing technology transfer for divesting plant (2016)

Member of the Sr. Management Team; Market Lead of product optimisation project aiming to globally rationalise and harmonise SKUs

Member of the Company’s inter-functional work stream for implementation of the new EU CTR

For the regulatory assessment and internal approval of advertising and scientific events