Position

Regulatory Affairs Manager – Biosimilars

Location

Madrid (on-site)

Experience

5+ years in Regulatory Affairs within biotech/biopharma

Key Responsibilities

• Monitor changes in the regulatory landscape, identify their impact, and propose solutions to maintain compliance.
• Define regulatory strategy for each product in coordination with Management and Business teams.
• Build strong collaborative partnerships with internal and external teams to ensure organizational success and patient safety.
• Identify and mitigate regulatory risks, adapting strategies to evolving regulations and Health Authority feedback.
• Interpret and communicate legislative changes that affect product registration, manufacturing, or development.
• Support the review of license and quality agreements for targeted geographies.
• Lead engagement with Health Authorities during Scientific Advice procedur...