Regulatory Affairs - Marlex Human Capital

Marlex Human Capital; Barcelona; Híbrido; EUR 42.000 - 62.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work setup

Professional development

Descripción de la vacante

Marlex Human Capital is seeking a Regulatory Affairs specialist to prepare and review regulatory dossiers, ensuring compliance for health authority submissions. You will coordinate technical documentation, respond to deficiency letters, and communicate changes to clients and authorities to maintain transparency.

The role requires a Bachelor in Health Sciences and 2 years in a similar position, with English proficiency.

Formación

• Bachelor in Health Sciences (Pharmacy, Biology or Chemistry) required.
• 2 years of experience in a similar regulatory role.
• Proficient level of English.
• MSc in Pharmaceutical Industry, Regulatory or related field highly valued.

Responsabilidades

• Prepare and review regulatory dossiers and ensure compliance for submissions.
• Coordinate collection and organization of technical documentation to meet regulations.
• Respond to inquiries and deficiency letters from health authorities and implement required changes.
• Communicate changes in products or facilities to clients and authorities for transparency.
• Implement internal policies related to registration processes and provide staff training.
• Oversee registration activities, including updating certificates and issuing permits.

Conocimientos

Regulatory affairs

Dossier preparation

Health authority knowledge

Strong communication

Proactive problem solving

Educación

Bachelor in Health Sciences (Pharmacy, Biology or Chemistry)

MSc in Pharmaceutical Industry or Regulatory

Descripción del empleo

In this role you support the pharmaceutical manufacturer by preparing and reviewing regulatory dossiers, ensuring compliance, and coordinating documentation for health authority submissions. You will liaise with authorities and clients on changes to manufacturing or control processes, and help implement and train staff on regulatory policies. You will oversee ongoing registration activities, including certificates and permits, contributing to a compliant, transparent operation. This role offers professional development in a high-quality pharmaceutical environment and a hybrid work setup.

• Job stability
• Prepare and review product registration dossiers and ensure regulatory compliance for submissions
• Coordinate collection and organization of technical documentation to meet regulations
• Respond to inquiries and deficiency letters from health authorities and implement required changes
• Communicate changes in products or facilities to clients and authorities for transparency
• Implement internal policies related to registration processes and provide staff training
• Oversee registration activities including updating certificates and issuing permits
• Bachelor in Health Sciences (Pharmacy, Biology or Chemistry)
• 2 years of experience in a similar role
• Proficient level of English
• MSc in Pharmaceutical Industry, Regulatory or related field is highly valued
• strong communication
• proactive problem solving
• regulatory affairs
• dossier preparation and submission
• knowledge of health authority requirements