Head of Legal & Compliance Officer | Grünenthal Italia

Michela Barbarossa
Head of Legal & Compliance Officer | Grünenthal Italia
Career biography
Fully qualified lawyer specialised in pharmaceutical law, corporate law, and Legislative Decree 231/2001 compliance, she has over 14 years of experience gained in complex multinational corporate environments and leading law firms.
She joined Grünenthal in February 2020, assuming responsibility for legal matters relating to both the Group’s commercial affiliate and manufacturing site in Italy. In January 2023, she was appointed Head of Legal & Compliance and became a member of the Board of Directors of Grünenthal Italia, as well as of the joint venture with Kyowa Kirin. As a Board member, she actively contributes to the company’s most significant strategic decisions, with a particular focus on managing legal, regulatory, and reputational risks.
Her professional background includes significant experience at Danone Group and Mediaset, where she developed extensive expertise in regulatory compliance (including Legislative Decree 231/2001, antitrust, and anti-corruption), data protection (GDPR), and corporate governance. Earlier in her career, she spent several years practising at the law firm Perroni & Associati.
She is the author of several publications on data protection and the GDPR and has served as a lecturer in university master’s programmes.
Career biography
What are the most significant cases, projects, or transactions that you and your legal team have recently been involved in?
Over the last year, the Legal & Compliance Department has been involved in several highly strategic initiatives that have had a significant impact on the transformation and growth of the organisation.
A key priority was supporting a major reorganisation, which required a comprehensive review of the governance framework, delegation model, decision-making processes, and compliance structure. This complex transition involved extensive coordination across functions while ensuring full business continuity with no disruption to operations.
At the same time, the team played a proactive business-partnering role by helping shape and implement elements of the company’s evolving business model. We were also deeply involved in the launch readiness activities for a new product, working closely with Commercial, Market Access, Medical, Regulatory, and Supply Chain teams to properly support the structure of the launch process.
Another significant area of focus was the assessment and implementation of complex manufacturing and supply-chain frameworks for non-EU markets, particularly the United States and Australia. This included advising on contract manufacturing contracts, assessing tax and legal implications, addressing customs and trade matters—including the impact of U.S. tariffs—and supporting the importation of highly regulated active pharmaceutical ingredients.
In parallel, the department has been actively supporting senior management on key industry-wide developments, including the implications of Most Favoured Nation (MFN) policies on pharmaceutical pricing and market access, as well as the ongoing revision of the Italian National Pharmaceutical Formulary, assessing potential legal, regulatory, and commercial consequences for the business.
Finally, we have managed several sensitive negotiations with distributors and other market stakeholders, helping the company protect its interests while maintaining strong and sustainable commercial relationships.
How do you approach managing legal aspects during periods of instability or crisis to ensure the organisation’s resilience?
Periods of instability and crisis are no longer exceptional events, but rather the new structural context in which the industrial sector operates.
In this scenario, the Legal Department often plays a central role: thanks to its deep understanding of the regulatory framework and its position as a key point of contact with authorities and regulatory bodies.
In the pharmaceutical market, in particular, some risks have historically been predictable and already embedded in business models—such as the loss of patent protection. Alongside these, however, increasingly unpredictable and discontinuous risks are emerging (regulatory, geopolitical, supply chain, reputational), to which organisations must be structurally prepared to respond, not only in a reactive way but also through proactive and anticipatory approaches.
To strengthen this resilience, a key starting point is the systematic update of a SWOT analysis.
Equally important is organisational culture. It is essential to foster an environment in which internal leaders are not only capable of understanding the complexity of the external landscape, but also of effectively communicating it within the organisation. The ability to explain critical scenarios, potential developments, and operational implications becomes a key enabler of organisational resilience. In times of crisis, this clarity of communication helps prevent fragmentation, accelerates decision-making, and ensures a more coordinated and consistent response across functions.
Ultimately, flexibility and the acceptance of a certain degree of intentional inefficiency are also key elements of resilience. While operational efficiency has long been a dominant principle, resilience often requires a more balanced approach. For example, maintaining multiple qualified suppliers, even at the cost of higher complexity or reduced short-term efficiency, can be crucial to avoiding supply chain disruptions. This redundancy acts as a safeguard, ensuring continuity of supply even when unforeseen disruptions occur.
General counsel often speak of the need to be strategic to reach the pinnacle of the profession. What does being strategic mean to you?
Being strategic as a head of the legal department or as general counsel means having the ability to plan for the long term, coordinate resources and anticipate obstacles in order to achieve a complex objective. In-house lawyers in the pharmaceutical sector also have a wonderful opportunity to demonstrate their strategic thinking by being proactive in proposing business solutions. No one is better placed than those who know the rules to suggest a structure that can expand business opportunities whilst complying with the regulations.
Have you had any experiences during your career as a lawyer that stand out as particularly unique or interesting?
What has characterised my career is undoubtedly the fact that I have been exposed to complex issues with high media profile from a very young age. When I was at the law firm, I was immediately entrusted with a great deal of responsibility, and this subjected me to considerable pressure regarding results and the quality of my work. It was a formative experience that has strengthened me and now enables me to manage initiatives with significant economic impact with care and creativity but never fear.
For example, when I first took over as head of the department, I found myself having to deal with the loss of exclusivity for a blockbuster product and had to come up with out-of-the-box solutions to manage the situation.