Regulatory Affairs Biosimilar Specialist LATAM Location: Madrid
Experience: 5+ years in Regulatory Affairs within innovative biopharmaceuticals and/or biosimilars
At Exeltis, we continue to grow and we are looking for a Regulatory Affairs Biosimilar Specialist ready to take the next step in their career in an international, innovative and high-impact environment.
If you are passionate about Regulatory Affairs, have strong experience in biosimilars, and enjoy defining strategies, anticipating risks and working cross-functionally with different teams, this could be your next great opportunity.
We are looking for an experienced Regulatory Affairs professional with a strategic mindset, strong influencing skills and solid expertise in biosimilars and innovative biopharmaceuticals.
We want to add a proactive, solution-oriented and collaborative person who can provide regulatory insight, business alignment and strong execution in a integral and evolving environment.
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.
Providing regulatory leadership and expert guidance to core project teams and sub-teams.
Supporting Business Development and Commercial Operations in the review of License Agreements and Quality Technical Agreements for target geographies.
Providing regulatory guidance in product development review boards, project teams and scientific committee meetings.
Defining and implementing regional regulatory strategies for innovative drugs, complex generics and biosimilars in line with business objectives.
Advising R&D; and Business Development teams on regulatory requirements for registration dossiers and Scientific Advice submissions.
Ensuring regulatory risks identified during product development and/or post-app

📌 Business & Compliance Officer (España)
🏢 Exeltis
📍 España