Regulatory Affairs Senior Officer - Medical Writer

buscojobs España; Pontevedra; A distancia; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical sector is seeking a Medical Writer – Regulatory Affairs Senior officer. This role involves managing and writing regulatory documents and strategies while ensuring compliance with project timelines. Candidates should have a scientific background and a minimum of three years experience in regulatory writing. Flexible working conditions are offered, including home office and hybrid models, alongside professional development opportunities.

Servicios

Permanent contract

Homeoffice & Hybrid or Remote Model

Training and personal development program

Formación

• Minimum of 3 years in a similar role working in regulatory writing in the pharma sector.
• Strong knowledge of regulatory affairs is required.
• Fluency in English (C1) is mandatory; Spanish is a significant advantage.

Responsabilidades

• Writing regulatory documents to support drug development.
• Design of regulatory roadmaps and strategies for MAA.
• Managing timelines and reporting for client and partner projects.

Conocimientos

Regulatory Affairs

Client-oriented communication

Proactive mindset

Fluency in English

Educación

Scientific / biomedical background

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 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 3 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?

Permanent contract.

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.