Medical Writer – Regulatory Affairs Senior Officer

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

Descripción de la vacante

A leading company in regulatory affairs is seeking a Medical Writer – Regulatory Affairs Senior Officer to join their team. This role involves writing regulatory documents, managing client relationships, and developing regulatory strategies. Ideal candidates will have a scientific background, 4+ years of experience, and strong communication skills. The position offers a permanent contract with a hybrid or remote working model.

Servicios

Permanent contract

Home office & hybrid or remote model

Training and personal development programs

Formación

• Minimum 4 years in regulatory writing role within pharma or startups.
• Fluency in English (C1 or higher); Spanish is a plus.

Responsabilidades

• Writing regulatory documents to support drug development.
• Preparing eCTD dossier clinical/nonclinical documents.
• Managing client and partner relationships.

Conocimientos

Client-oriented communication

Proactive mindset

Knowledge of regulatory affairs

Educación

Scientific or 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 experts. This role is ideal for someone passionate about science and eager to leverage their experience in a new, challenging professional environment.

Main Responsibilities :

1. Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD, IB).
2. Preparing eCTD dossier clinical/nonclinical documents (M2).
3. Designing regulatory roadmaps.
4. Developing regulatory strategies for MAA.
5. Managing client and partner relationships: defining milestones, planning, executing tasks, managing timelines, and project reporting.
6. Communicating with health authorities regarding drug development procedures.
7. Submitting and managing applications through portals (CTIS, IRIS, etc.).

Requirements :

• Educational Background : Scientific or biomedical background.
• Experience : Minimum of 4 years in a similar regulatory writing role within the pharma sector, or in spin-offs/startups.
• Skills and Competencies : Strong knowledge of regulatory affairs, excellent client-oriented communication skills, proactive mindset.
• Technical Skills : 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.
• Home office & hybrid or remote model (located anywhere in Spain).
• Variety of projects, new challenges, and experiences.
• Training and personal development programs.