Regulatory Affairs Specialist

beBeeRegulatory; Madrid; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

Una empresa líder en biotecnología busca un Especialista en Asuntos Regulatorios para implementar estrategias a nivel global. El candidato ideal tendrá experiencia en la redacción y revisión de documentos regulatorios, y una sólida comprensión de las regulaciones relevantes. Se ofrece un contrato permanente con un paquete salarial atractivo y numerosos beneficios como seguro de vida y un servicio médico in situ.

Servicios

Seguro de vida y accidentes

Servicio médico in situ

Clube de Ahorros

Plataforma de aprendizaje de idiomas

Sesiones ilimitadas con psicólogo

Servicio de transporte Cabify para empleados

Formación

• Mínimo de 3-5 años de experiencia en Asuntos Regulatorios en biopharma o biosimilares.
• Capacidad para aplicar el conocimiento de manera estratégica a lo largo del ciclo de vida del producto.
• Conocimiento de políticas de desarrollo de medicamentos farmacéuticos y biológicos.

Responsabilidades

• Definir e implementar estrategias regulatorias globales para garantizar el cumplimiento normativo.
• Redactar secciones CMC regulatorias y revisar documentos de dossier.
• Monitorear el panorama regulatorio y proporcionar análisis interpretativos.

Conocimientos

Conocimiento de regulaciones EMA, FDA e ICH

Experiencia en escritura y revisión de documentos CMC

Fluidez en inglés

Conocimiento de Ciencias de la Salud

Entendimiento de expectativas de HA

Educación

Título en Ciencias de la Vida / Salud

Descripción del empleo

The position of Regulatory Affairs Specialist is responsible for defining and implementing global regulatory strategies to ensure compliance with national and international regulations.

Key responsibilities include writing regulatory CMC sections, reviewing dossier CMC and regulatory documents, providing strategic guidance on regulatory CMC topics, and ensuring product compliance throughout the product lifecycle.

Additionally, this role involves monitoring the regulatory landscape, providing interpretive analysis and implications on local and regional regulatory guidance documents, regulations or directives, and maintaining regional requirements and submission templates.

The ideal candidate will have a degree in Life / Health Sciences, fluency in English, and experience working within Regulatory Affairs in biopharmaceuticals and / or biosimilars.

The following skills and qualifications are required :

• Minimum 3-5 years' experience in Regulatory Affairs in biopharmaceuticals and / or biosimilars
• Strong understanding of HA expectations and ability to apply knowledge strategically and operationally throughout the product lifecycle
• Experience in regulatory writing and reviewing dossier CMC and regulatory documents
• Knowledge of EMA, FDA, and ICH regulations, guidelines, and pharmaceutical and biologic drug development policies
• Fluent English, with knowledge of Spanish and other languages an asset

We offer a permanent contract, 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, Cabify transportation service for employee use, development plans, internal mobility policy, and many more benefits.

Our selection process includes an in-person / virtual interview and test. We care that you feel guided throughout each selection process and know what to expect from us, so we will always try to inform you of the status of the process.