Regulatory Affairs Senior Officer - Medical Writer

ASPHALION; Ourense; Híbrido; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

ASPHALION seeks a Medical Writer – Regulatory Affairs Senior Officer to join their dedicated team. This role involves documenting regulatory submissions and strategic planning for drug development. Ideal candidates will possess a scientific degree, extensive experience in regulatory writing, and exceptional communication skills. Enjoy a permanent contract with a flexible work model, various projects, and opportunities for training and development.

Servicios

Permanent contract

Home office & hybrid or remote work model

Variety of projects and learning opportunities

Training and personal development programs

Formación

• Minimum of 3 years in regulatory writing in the pharma sector.
• Fluency in English (C1 or higher); Spanish is a significant advantage.

Responsabilidades

• Write regulatory documents for drug development.
• Manage client relationships and project timelines.
• Prepare eCTD dossier clinical/nonclinical documents.

Conocimientos

Knowledge of regulatory affairs

Client-oriented communication

Proactive mindset

Educación

Scientific or biomedical degree

Herramientas

MS Office Suite

Descripción del empleo

We are seeking 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 advance their career in a new, challenging environment.

Main Responsibilities:

• Ensure the timely and accurate execution of projects according to defined timelines.
• Write regulatory documents to support drug development (SA, PIP, ODD, IMPD, IB).
• Prepare eCTD dossier clinical/nonclinical documents (Module 2).
• Design regulatory roadmaps and strategies for MAA.
• Manage client and partner relationships: define milestones, plan and execute tasks, manage timelines, and report on projects.
• Coordinate with health authorities for drug development procedures.
• Handle submissions and application management through portals (CTIS, IRIS, etc.).

Requirements:

• Educational Background: Scientific or biomedical degree.
• Experience: Minimum of 3 years in regulatory writing within the pharma sector, or in a spin-off/start-up environment.
• Skills and Competencies: Strong knowledge of regulatory affairs, excellent client-oriented communication skills, proactive mindset.
• IT Skills: Advanced proficiency in 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 work model (located anywhere in Spain).
• Variety of projects, new challenges, and learning opportunities.
• Training and personal development programs.