Regulatory Affairs Biosimilars Specialist – LATAM (Relocate to Madrid)

About the role

Exeltis is seeking an experienced Regulatory Affairs Specialist focused on biosimilars for the LATAM region, with relocation to Madrid. You will work in a high‑visibility, cross‑functional environment, shaping regulatory strategies for complex biopharmaceutical products and ensuring successful market entry across multiple territories.

Key responsibilities

• Monitor regulatory landscape changes and assess impact on product pipelines.
• Define and align regulatory strategies with the Regulatory Affairs Director, Business Development, and Commercial teams.
• Develop detailed regulatory plans that support business priorities and mitigate identified risks.
• Provide regulatory leadership to project teams, interpreting legislation and health‑authority feedback.
• Support Business Development and Commercial Operations in reviewing License Agreements and Quality Technical Agreements.
• Lead interactions with Health Authorities during Scientific Advice procedures and prepare submission dossiers (IBs, INDs, CTAs, MAAs, etc.).

Required profile

• 5+ years of regulatory affairs experience in innovative biopharmaceuticals or biosimilars.
• Strategic mindset with strong influencing and collaboration skills.
• Proactive, solution‑oriented approach and ability to work in a global, evolving environment.

Required skills

• In‑depth knowledge of biosimilar regulatory requirements.
• Experience preparing and reviewing regulatory submission documents.
• Ability to interpret and apply international legislation and health‑authority guidance.

What we offer

• Opportunity to lead regulatory strategy for high‑impact products.
• International exposure with cross‑functional collaboration.
• Relocation support to Madrid and a dynamic, innovative work environment.