Regulatory Affairs Senior Officer - Medical Writer

ASPHALION; Lugo; A distancia; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading company in regulatory affairs is looking for a Medical Writer to support drug development projects. The role involves writing essential regulatory documents and managing client interactions in a dynamic, hybrid environment, offering opportunities for personal development. Ideal candidates will have a scientific background and strong regulatory knowledge.

Servicios

Permanent contract

Homeoffice & Hybrid or Remote Model

Training and personal development program

Well-being programs

Professional and inclusive work environment

Formación

• Minimum of 3 years' experience in regulatory writing in pharma sector.
• Fluency in English (C1 or higher); Spanish is advantageous.
• Strong knowledge of regulatory processes required.

Responsabilidades

• Write regulatory documents for drug development.
• Manage client relationships and project timelines.
• Design regulatory strategies and roadmaps.

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 :

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.

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.

Internal activities & RSC Activities

Equal Opportunity Employer