Regulatory Affairs Associate - International Markets

Chemo; Madrid; Presencial; EUR 42.000 - 60.000; Jornada completa

Descripción de la vacante

Chemo, empresa farmacéutica global con sede en Madrid, busca un/a Regulatory Affairs Associate para Mercados Internacionales. Trabajará de manera autónoma, coordinando expedientes y proyectos reguladores a nivel internacional, desde la preparación de dossiers hasta la gestión de consultas de autoridades sanitarias.

El/la candidato/a ideal cuenta con experiencia en Regulatory Affairs en la industria farmacéutica, dominio del CTD e ICH, y capacidad para colaborar en entorno matricial e

Formación

• Universidad en Ciencias de la Salud (Farmacia, Química, Biología) o campo relacionado.
• Fluido en español e inglés obligatorio.
• 3–4 años de experiencia progresiva en Regulatory Affairs.
• Experiencia en Mercados Internacionales.
• Conocimientos sólidos de GMP, directrices ICH y formato CTD.
• Dominio de Word, Excel y PowerPoint.
• Disposición para viajar ocasionalmente.

Responsabilidades

• Monitorear e interpretar requisitos regulatorios en mercados internacionales y asegurar cumplimiento.
• Preparar y mantener expedientes regulatorios para nuevas autorizaciones y actividades de mantenimiento.
• Coordinar presentaciones regulatorias con licenciatarios y afiliados, asegurando registro y seguimiento.
• Colaborar con los interesados para responder a consultas de autoridades sanitarias.
• Apoyar procesos de cambios y renovaciones de registro (lifecycle).
• Ser contacto regulatorio principal para productos asignados.
• Mantener registros regulatorios y sistemas de inteligencia regulatoria actualizados.
• Comunicar estrategias regulatorias, riesgos y plazos a partes interesadas.
• Contribuir a desarrollo y mejora de procedimientos regulatorios.

Conocimientos

Regulatory expertise

International markets

Bilingual Spanish/English

Documentation & submissions

Educación

University degree in Health Sciences

Herramientas

Word

Excel

PowerPoint

Descripción del empleo

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

Chemo is a global 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 received from Health Authorities in collaboration with relevant stakeholders.
• Support the preparation and submission of lifecycle management activities, including variations, renewals, and other regulatory maintenance procedures.
• Act as the primary regulatory contact for assigned products, providing regulatory guidance and expertise to cross-functional teams throughout the product lifecycle.
• Collaborate with licensees and affiliates to assess the regulatory impact of manufacturing, quality, and product-related changes, ensuring continued compliance in all relevant markets.
• Maintain accurate regulatory records, databases, and tracking systems to ensure proper document control and regulatory intelligence management.
• Communicate regulatory strategies, risks, timelines, and project status updates to internal stakeholders, supporting informed decision-making.
• Provide regulatory input during product development and business initiatives to ensure regulatory requirements and market-specific expectations are appropriately addressed.
• Develop, review, and continuously improve regulatory procedures, work instructions, and best practices to support operational excellence.
• Support affiliate and partner audit readiness activities by ensuring the availability, accuracy, and completeness of regulatory documentation.
• Contribute to knowledge-sharing and onboarding activities by training and mentoring new team members in areas of regulatory expertise.

What do you need?

• University degree in Health Sciences, such as Pharmacy, Chemistry, Biology, or a related field.
• Fluent Spanish and English are mandatory.
• Additional languages will be considered a plus.
• 3-4 years of progressive experience in Regulatory Affairs within the pharmaceutical industry.
• Proven experience in International Markets.
• Solid knowledge of general pharmaceutical legislation and regulatory requirements.
• Knowledge of GMP.
• Expertise in ICH guidelines.
• Knowledge of CTD dossier format and content.
• Proficiency in standard software tools such as Word, Excel, and PowerPoint.
• Willingness to travel occasionally.

We will also value:

• Ability to work both collaboratively and autonomously.
• Strong multitasking skills and flexibility to adapt to changing priorities.
• Ability to thrive in dynamic, matrix, and international working environments.
• Strong oral and written communication skills.
• Collaborative mindset, with the ability to influence and engage stakeholders across different levels, cultures, and functions.
• Proactive, solution-oriented, and continuous improvement mindset.

Our benefits!

• Permanent contract
• Flexible start time from Monday to Friday
• Attractive salary package
• Life and accident insurance
• Ticket restaurant
• On-site medical service
• Benefits and Savings Club
• Training and language learning platform
• Wellness platform with unlimited free psychologist sessions
• Development plans and internal mobility policy
• And much more!

What will the selection process look like?

• Initial contact by phone or email
• 1-2 virtual/in-person interviews
• Ongoing communication throughout the process

Do you think this role is not for you?

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EQUAL OPPORTUNITIES COMMITMENT

At Chemo, we are committed to equal opportunities and to building a diverse and inclusive workplace. All applications will be considered without discrimination based on gender, gender identity or expression, ethnicity, nationality, religion, sexual orientation, age, disability, or any other personal, physical, or social condition.