Regulatory Affairs Head

hace 2 semanas


Madrid, España Merck Group A tiempo completo

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 for Spain, you will play a pivotal role in leading, building, and managing a dynamic team of three Regulatory Affairs professionals. You will oversee and coordinate the daily operations of the Regulatory department, ensuring seamless submission management from planning to finalization of local submissions. Your expertise will define the Health Authority (HA) engagement strategy, acting as the primary point of contact for local Health Authorities. By fostering strong relationships with these authorities, you will integrate their insights into local strategic planning.
In this position, you will develop country product plans that align with global and regional strategies, collaborating closely with partners and key stakeholders at local, regional, and global levels. You will also provide critical support for clinical trials as needed and review and approve promotional materials to ensure compliance with local regulations.
As a leader, you will coach and engage your team to work efficiently and proactively, enabling their personal growth and helping them reach their full potential. Additionally, you will lead regional process projects or initiatives and be an active member of the Regional Regulatory Leadership Team.
The position is based in Madrid, Spain.

**Who You Are**:

- You hold a university degree or PhD in pharmacy.
- You bring 10-15 years of experience in the Regulatory Affairs field, with a proven track record of leading high-performance teams.
- Your knowledge of applicable EU and Spanish regulations is current and comprehensive.
- You have a well-established network with local Health Authorities.
- Your strong stakeholder management, project management, and communication skills enable you to navigate complex environments effectively.
- You excel at time management, gaining alignment, and executing strategic activities successfully.
- You understand how to assess and evaluate the impact of change within a team or organization.
- You prioritize competing tasks effectively in a fast-paced, dynamic environment.
- You are fluent in both Spanish and English, allowing you to interact effectively with all levels of management.

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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



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