Since 1929, ESTEVE has been driven by a clear and powerful purpose: improve people’s lives. Headquartered in Barcelona, we are a global pharmaceutical company with affiliates in Spain, Portugal, Italy, Germany, France, the UK, and the USA, as well as world-class production sites in Mexico and China supporting our global CMO business.

We are on an exciting growth journey, transforming into a leading international specialty pharma company, focused on highly specialized medicines that address unmet medical needs. At the heart of everything we do are our core values: people matter, transparency, and accountability.

We care, we do: Our commitment goes beyond medicine. We care about making a positive impact on people, the environment, and the way we do business.

1. FUNCTIONAL CONTENT

Main Role

The Regulatory Affairs Specialist will be responsible for managing the regulatory lifecycle of US FDA-approved products, ensuring ongoing compliance and supporting regulatory activities for the ongoing new product development projects.

This role requires close collaboration with cross-functional teams including Global Regulatory colleagues, clinical, pharmacovigilance, and external partners to ensure timely and accurate regulatory submissions and strategic input throughout the product lifecycle.

Roles:

• Prepare, review, and submit FDA documentation including supplements, annual reports, and amendments.
• Monitor and interpret changes in FDA regulations and assess impact on existing products.
• Maintain regulatory compliance for marketed products, including labeling and post-market surveillance.
• Collaborate with different internal and external stakeholders in transversal projects, providing the regulatory recommendation for the success of the project.
• Support regulatory activities for product development projects, collaborating with project teams to develop regulatory strategies and timelines.
• Support any other general activity required in the department, including meeting preparations, dossier archiving, RIMS, etc.

2. ORGANIZATION CHART & JOB RELATIONSHIPS

Line Manager:

• Global Regulatory Affairs Product Development & US

Direct Reporting:

• N/A

External Relationships:

• Internal: Global Regulatory Affairs Department, Project Management, Alliance Manager, PMO, Global Marketing, Clinical Development
• External: Partners, CRO

3. JOB PROFILE

Required Studies:

• Bachelor’s degree in Life Science / Pharma / Biology / Chemistry

Other Specialized Knowledge:

• Strong understanding of US FDA regulatory pathways and guidance documents
• Proven experience with FDA submissions
• Experience supporting development projects and working with cross-functional teams is a plus
• Excellent interpersonal communication skills (written and verbal communications)
• Excellent management of PowerPoint, Excel, Microsoft 365

Languages:

• Fluent English
• Spanish
• Other languages will be a plus

Professional Experience:

• Minimum of experience: 3–5 years in Regulatory Affairs in Pharmaceutical Company or Service Provider (CRO)

Ready to join us on our purpose to improve people’s lives?  Become part of a team where your passion can make a real difference.