Regulatory Affairs Head
hace 2 días
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.
- Your advanced skills in standard MS Office and business applications enhance your productivity, and you are willing to travel as needed for the role.
Role: Manager 4
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