Medical Writer Expert – Regulatory Affairs

ASPHALION; Navarra; A distancia; EUR 40.000 - 70.000; Jornada completa

Descripción de la vacante

ASPHALION is seeking a Medical Writer Expert in Regulatory Affairs with a scientific background and at least 8-10 years of experience. The role involves crafting regulatory documents, managing projects, and liaising with health authorities in a hybrid or remote model across Spain. Join a team dedicated to quality, passion, and personal development.

Servicios

Homeoffice & Hybrid or Remote Model

Training and Personal Development Program

Physical, Psychological and Emotional Well-Being Programs

Formación

• Minimum 8-10 years in regulatory writing in the pharma sector.
• Strong knowledge of regulatory affairs.
• Fluency in English (C1 or higher), Spanish is a significant advantage.

Responsabilidades

• Writing regulatory documents to support drug development.
• Client and partner management including task execution and project reporting.
• Liaison with health authorities for drug development procedures.

Conocimientos

Regulatory Affairs Knowledge

Client-oriented Communication

Advanced IT Proficiency

Educación

Scientific / Biomedical Background

Herramientas

MS Office Suite

Descripción del empleo

Medical Writer Expert – Regulatory Affairs

Medical Writer Expert – Regulatory Affairs

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Direct message the job poster from ASPHALION

We are looking for a Medical Writer Expert– Regulatory Affairs for our team of development, strategy and scientific writing expert unit. Someone who loves Science and wants to use their experience in a new challenging professional step.

Main responsibilities :

The Medical Writer will be in charge of the timely and correct execution of projects according to defined timelines :

• Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD ,IB )
• Writing eCTD Dossier clinical / nonclinical documents (M2)
• Design of regulatory roadmaps
• Regulatory strategy for MAA
• Client and partner management : define milestones, planning and execution of tasks, manage timelines, project reporting
• Liaison with health authorities for drug development procedures
• Submission and management of applications through portals (CTIS, IRIS, ...)

Requirements :

• Educational Background : Scientific / biomedical background
• Experience : Minimum of 8-10 years in a similar role working in regulatory writing in pharma sector, or spin-off / start up
• 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 working at Asphalion?

Homeoffice & Hybrid or Remote Model (You can be located anywhere in Spain!)

Wide variety of projects, new challenges and experiences.

Training and personal development program.

A professional, inclusive and high-performance work environment to develop your skills and grow your career. A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship.

A highly & dynamic working environment with employees from more than 15 nationalities.

Our people and their well-being are our priority : Physical, psychological and emotional well-being programme.

Equal Opportunity Employer

Seniority level

Seniority level

Associate

Employment type

Employment type

Full-time

Job function

Job function

Consulting

Pharmaceutical Manufacturing

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