Senior Back End Engineers (Java / kotlin)

Athenaworks; Murcia; Presencial; EUR 40.000 - 55.000; Jornada completa

Descripción de la vacante

A leading company is seeking a Medical Writer – Regulatory Affairs Senior Officer to join their team. The role involves writing regulatory documents, designing regulatory strategies, and managing client relationships. Candidates should have a scientific background and at least 4 years of experience in regulatory writing within the pharma sector. This position offers a permanent contract with flexible working options, including home office and hybrid models.

Servicios

Permanent Contract

Homeoffice & Hybrid or Remote Model

Training and Personal Development Program

Formación

• Minimum of 4 years in regulatory writing in pharma sector.
• Fluency in English (C1 or higher) is mandatory.

Responsabilidades

• Writing regulatory documents to support drug development.
• Design of regulatory roadmaps and strategies.
• Client and partner management.

Conocimientos

Communication

Proactive Mindset

Knowledge of Regulatory Affairs

Educación

Scientific / Biomedical Background

Herramientas

MS Office Suite

Descripción del empleo

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Descripción del trabajo

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 work 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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