Medical Writer – Regulatory Affairs Senior Officer

ASPHALION; Badajoz; A distancia; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading company in regulatory affairs seeks a Medical Writer – Regulatory Affairs Senior officer. You will be responsible for drafting key regulatory documents, managing projects, and liaising with health authorities. This is an opportunity to join a dynamic team, offering a permanent contract and flexible working conditions, including remote options.

Servicios

Homeoffice & Hybrid or Remote Model

Training and personal development program

Formación

• Minimum of 4 years experience in regulatory writing in pharma or similar.
• Fluency in English (C1 or higher) is mandatory; Spanish is a plus.

Responsabilidades

• Writing regulatory documents for drug development (SA, PIP, ODD).
• Designing regulatory roadmaps and strategies for MAA.
• Managing client relationships and project timelines.

Conocimientos

Regulatory affairs knowledge

Client-oriented communication

Proactive mindset

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 :

• 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 4 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.

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