Experteer Overview In this Regulatory Affairs role, you drive worldwide regulatory strategies for product registrations, renewals, and lifecycle activities, ensuring compliance across markets. You will lead the preparation and submission of dossiers, respond to Health Authority questions, and maintain alignment with evolving regulations. You’ll supervise Regulatory Affairs Technicians and collaborate with cross-functional teams to support product lifecycle and SOP governance. This is a chance to shape regulatory pathways for therapies that improve patient outcomes on a global scale.Compensaciones / Ventajas
- Assess worldwide regulatory strategies for registrations, renewals, and lifecycle activities across products and markets
- Prepare, review, and submit regulatory dossiers for registrations, renewals, variations, and post-approval changes
- Coordinate responses to Health Authority questions within established timelines
- Manage adaptation of licenses to current regulatory requirements
- Coordinate and approve packaging materials and labeling documentation for regulatory alignment
- Organize and supervise Regulatory Affairs Technicians to ensure timely,



high-quality work
- Assess regulatory impact of changes to product, manufacturing, or processes and implement required actions
- Monitor annual regulatory projects and ensure deliverables meet timelines
- Represent Regulatory Affairs in communications with affiliates, partners, and Health Authorities
- Maintain up-to-date regulatory knowledge and provide guidance on projects and initiatives
- Coordinate preparation, review, implementation, and maintenance of Regulatory Affairs SOPs
- Collaborate with cross-functional teams to provide regulatory support across the product lifecycle
- Support general activities and strategic initiatives within the Regulatory Affairs DepartmentResponsabilidades
- Bachelor in Health Sciences or engineering
- Experience in RRAA or technical pharmaceutical departments
- Analytical skills and attention to detail; ability to summarize and evaluate information
- Advanced level of Spanish and English (C1) and MS Office proficiencyRequisitos principales
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📌 Regulatory Affairs Manager (Barcelona)
🏢 Grifols
📍 Barcelona