Regulatory Affairs Senior Officer - Medical Writer

buscojobs España; Zaragoza; Híbrido; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

A dynamic company is seeking a Medical Writer – Regulatory Affairs Senior Officer to enhance their team. The role involves writing regulatory documents, managing applications, and developing strategies in regulatory affairs. Ideal candidates possess a background in science, 3+ years of experience, and strong IT skills.

Servicios

Permanent contract

Home office & hybrid or remote model

Variety of projects and challenges

Training and personal development programs

Formación

• Minimum of 3 years in regulatory writing within the pharma sector.
• Fluency in English (C1 or higher) is mandatory; Spanish is a significant advantage.

Responsabilidades

• Writing regulatory documents to support drug development.
• Preparing eCTD dossier clinical/nonclinical documents.
• Designing regulatory roadmaps and strategies for MAA.

Conocimientos

Strong knowledge of regulatory affairs

Excellent client-oriented communication skills

Proactive mindset

Advanced proficiency in IT tools

Educación

Educational background in science or biomedical fields

Herramientas

MS Office Suite

Descripción del empleo

We are looking for a Medical Writer – Regulatory Affairs Senior Officer for our team of development, strategy, and scientific writing experts. We seek someone who loves science and wants to take their experience to a new professional level.

Main responsibilities :

• Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD, IB)
• Preparing eCTD dossier clinical/nonclinical documents (Module 2)
• Designing regulatory roadmaps
• Developing regulatory strategies for MAA
• Managing clients and partners: defining milestones, planning, executing tasks, managing timelines, and reporting
• Coordinating with health authorities for drug development procedures
• Submitting and managing applications through portals (CTIS, IRIS, etc.)

Requirements :

Educational background in science or biomedical fields.

Experience : Minimum of 3 years in regulatory writing within the pharma sector, or in spin-offs/startups.

Skills and competencies :

Strong knowledge of regulatory affairs.

Excellent client-oriented communication skills and proactive mindset.

Advanced proficiency in IT tools (MS Office Suite).

Languages : Fluency in English (C1 or higher) is mandatory; Spanish is a significant advantage.

Why work at Asphalion?

• Permanent contract
• Home office & hybrid or remote model (anywhere in Spain)
• Variety of projects, new challenges, and experiences
• Training and personal development programs