Descripción del puesto:
In a nutshell ?
Position: Regulatory Affairs Associate – International Markets
Location: Madrid
Experience: 3-4 years of experience in Regulatory Affairs within the pharmaceutical industry, with a focus on international markets
Want to know more? ?
Chemo is a integral pharmaceutical company specialized in the development, production, and commercialization of active pharmaceutical ingredients (APIs) and medicines, committed to quality, innovation, and access to treatments worldwide.
We are currently looking for a Regulatory Affairs Associate – International Markets to join our team in Madrid. If you have solid Regulatory Affairs experience in the pharmaceutical industry, enjoy working in an international environment, and are motivated by coordinating regulatory dossiers and projects with autonomy, this could be the right opportunity for you.
This role plays a key part in regulatory dossier coordination across multiple territories worldwide,
combining technical regulatory expertise with strong project monitoring capabilities to support both new submissions and post-approval maintenance activities.
What are we looking for? ?
We are looking for an experienced, self-driven, and solution-oriented professional with a strong regulatory background and the ability to work independently in a dynamic, matrix, and international environment.
The challenge ?
- Monitor, interpret, and implement regulatory requirements applicable to company products across international markets, ensuring alignment with internal policies, procedures, and compliance standards.
- Prepare, compile, and maintain regulatory dossiers and supporting documentation for new marketing authorization applications and post-approval activities.
- Coordinate regulatory submissions with licensees, affiliates, and business partners, ensuring timely filing and follow-up through to approval.
- Evaluate and contribute to responses to regulatory queries, deficiency letters, and requests re
📌 Regulatory Affairs Associate (Madrid)
🏢 Chemo
📍 Madrid