Head of Regulatory Affairs Italy Pricing Dir

11 ore fa

Roma, Lazio, Italia The businesses of Merck KGaA, Darmstadt, Germany A tempo pieno

Work Your Magic with us  

Ready to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role:

As the Regulatory Affairs Head Italy, you lead, build, and manage a team of 3 Regulatory Affairs professionals, and you oversee and coordinate the day-to-day activities for the Regulatory department in Italy.

You lead the local submission management from planning to finalizing local submissions. You define the Health Authority (HA) engagement strategy, and you serve as point of contact for local Health Authorities. You maintain a close relationship with the local HA and include HA insights into local strategic planning.

You are also acting as representative in the local industry association.

In your role you develop country product plans based on global/regional strategy and business plans. You communicate closely with partners and key stakeholder functions at local, regional, and global level, as applicable. As applicable and required, you provide relevant support for clinical trials. You review and approve promotional material and ensure submission to local HAs as required.

As Regulatory Head Italy you lead and coach the team, engage to work efficiently and in a pro-active manner. You enable the development on your team members, support their personal growth to reach their full potential.

You lead, as applicable, regional process projects or initiatives and are a member of the Regional Regulatory Leadership Team.

Who you are:

University degree or PhD in pharmacy10-15 years of experience in Regulatory Affairs field (local RA proficiency) and in positioning leading high-performance teamsExcellent and up to date knowledge and understanding of applicable EU and Spanish regulationsWell established network with local Health AuthoritiesStrong stakeholder management, project management and communication skillsAbility to manage time effectively, gain alignment and successfully execute future strategic activities.Ability to focus on implementing measurements and taking corrective actions on processes management.Be comfortable, understand how to assess & evaluate the impact of change within a team/organization.Effectively prioritizes competing tasks in a fast-paced and dynamic environment.High proficiency in Spanish and English; knowledge of italian language is required.Ability to interact effectively with all levels of management.Effective time management skills to multi-task several initiatives with demonstrated ability to achieve success.Advanced skills in with all standard MS office & business applications.Availability to travel is needed.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity

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