Regulatory Affairs Senior Officer - Medical Writer

ASPHALION; Granada; Híbrido; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

ASPHALION is seeking a Medical Writer – Regulatory Affairs Senior Officer to join their team. The role involves writing and preparing regulatory documents, managing client relationships, and ensuring compliance with health authority guidelines. This permanent position allows for a flexible working arrangement within Spain and offers opportunities for professional development.

Servicios

Permanent contract

Home office & hybrid or remote model

Variety of projects and new challenges

Training and personal development opportunities

Formación

• Minimum 3 years in regulatory writing roles.
• Fluent in English (C1 or higher); Spanish a plus.
• Experience in pharmaceutical or start-up environments.

Responsabilidades

• Write regulatory documents for drug development (SA, PIP, etc.).
• Prepare eCTD Dossier clinical/nonclinical documents.
• Manage timelines and liaise with health authorities.

Conocimientos

Regulatory affairs knowledge

Client-oriented communication

Proactive mindset

Advanced IT tools proficiency

Educación

Scientific or biomedical degree

Herramientas

MS Office Suite

Descripción del empleo

We are looking for a Medical Writer – Regulatory Affairs Senior Officer to join our team of development, strategy, and scientific writing experts. If you love science and want to take your experience to a new professional level, this opportunity is for you.

Main responsibilities:

The Medical Writer will be responsible for the timely and accurate execution of projects according to defined timelines:

• Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD, IB)
• Preparing eCTD Dossier clinical/nonclinical documents (Module 2)
• Designing regulatory roadmaps
• Developing regulatory strategies for MAA
• Managing clients and partners: defining milestones, planning, task execution, managing timelines, and reporting
• Liaising with health authorities for drug development procedures
• Submitting and managing applications through portals (CTIS, IRIS, etc.)

Requirements:

Educational background: Scientific or biomedical degree

Experience: Minimum of 3 years in a similar regulatory writing role within the pharma sector, or spin-off/start-up environment

Skills and competencies:

Strong knowledge of regulatory affairs, excellent client-oriented communication skills, proactive mindset, and advanced proficiency in IT tools (MS Office Suite).

Languages: Fluent in English (C1 or higher) is mandatory; Spanish is a significant advantage.

Why work at Asphalion?

Permanent contract, home office & hybrid or remote model (anywhere in Spain), a wide variety of projects, new challenges, training, and personal development opportunities.