Experteer Overview
In this Regulatory Affairs Manager role, you will steer regulatory activities for assigned products in Iberia, ensuring compliance with local and global requirements. You will lead interactions with competent authorities and coordinate registrations, variations, and lifecycle activities to align with business needs.
You will advise the business on regulatory matters and collaborate with cross-functional teams, contributing to innovation and market access. This position offers impact at scale within a diverse, inclusive environment dedicated to animal health.
Compensaciones / Incentivos
- Manage agency relations and regulatory communications with authorities
- Plan and direct regulatory activities, registrations, and lifecycle maintenance for assigned products
- Ensure timely submissions, change control and regulatory compliance
- Maintain proper regulatory records and ensure label, promotion,
and pharmacovigilance compliance
- Advise business on regulatory matters and provide strategic direction
- Participate in cross-functional teams and industry groups as needed
- Support clinical trial applications and import permits
- Travel up to 0-20% and operate in ES - Madrid locale
Responsabilidades
- Advanced degree in life sciences or equivalent
- Fluent English and Spanish and/or Portuguese (spoken and written)
- Minimum 2 years in regulatory affairs (animal health preferred)
- Strong communication skills and autonomous work style
- Experience with project teams and talent development
- Proficiency with Word, Excel and data management systems
- Ability to prioritize, multitask, assess risk
Requisitos principales
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📌 Regulatory Affairs Manager Iberia (Madrid)
🏢 Elanco
📍 Madrid