Regulatory Affairs Specialist - Biosimilars LATAM (relocation to Madrid, Spain)

Position: Regulatory Affairs Biosimilar Specialist LATAM

Experience: 5+ years in Regulatory Affairs within innovative biopharmaceuticals and/or biosimilars.

We are seeking a Regulatory Affairs Specialist - Biosimilars ready to take the next step in their career in an international, innovative and high-impact environment.

Responsibilities

• Monitoring changes in the regulatory landscape and identifying their impact on the company.
• Defining the regulatory strategy for each product in coordination with the Regulatory Affairs Director, Business Development and Commercial teams.
• Building regulatory plans aligned with business and functional priorities.
• Identifying regulatory risks, defining mitigation actions and driving implementation with cross-functional teams.
• Adapting regulatory strategies in line with evolving regulations and Health Authority feedback.
• Providing regulatory leadership and ex...