Regulatory Affairs Senior Officer - Medical Writer

ASPHALION; Logroño; Híbrido; EUR 35.000 - 60.000; Jornada completa

Descripción de la vacante

A multinational company is seeking a Regulatory Affairs Senior Officer - Medical Writer to join its team in Spain. This role involves writing regulatory documents, preparing clinical dossiers, and developing regulatory strategies. The ideal candidate will have a background in science or biomedical fields, strong communication skills, and a minimum of 3 years of regulatory writing experience. This position offers flexibility with home office options and promotes an inclusive working environment.

Servicios

Homeoffice, hybrid, or remote work options

Training and personal development programs

Well-being programs addressing physical, psychological, and emotional health

Formación

• Minimum of 3 years of experience in regulatory writing within the pharma sector or related startups/spin-offs.
• Fluency in English (C1 or higher); Spanish is a plus.
• Strong knowledge of regulatory affairs.

Responsabilidades

• Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD, IB).
• Preparing eCTD Dossier clinical/nonclinical documents (M2).
• Designing regulatory roadmaps.

Conocimientos

Regulatory writing

Client-oriented communication

Proactive mindset

Knowledge of regulatory affairs

Educación

Educational background in Science or Biomedical fields

Herramientas

MS Office Suite

Descripción del empleo

Regulatory Affairs Senior Officer - Medical Writer

We are seeking a Medical Writer – Regulatory Affairs Senior Officer to join our team of development, strategy, and scientific writing experts. This role is ideal for someone passionate about science and eager to take on a new professional challenge.

Main responsibilities :

• Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD, IB)
• Preparing eCTD Dossier clinical / nonclinical documents (M2)
• Designing regulatory roadmaps
• Developing regulatory strategies for MAA
• Managing client and partner relationships : defining milestones, planning, executing tasks, managing timelines, and reporting
• Liaising with health authorities for drug development procedures
• Submitting and managing applications through portals (CTIS, IRIS, etc.)

Requirements :

• Educational background in Science or Biomedical fields
• Minimum of 3 years of experience in regulatory writing within the pharma sector or related startups / spin-offs
• Strong knowledge of regulatory affairs
• Excellent client-oriented communication skills and proactive mindset
• Proficiency in IT tools (MS Office Suite)
• Fluency in English (C1 or higher); Spanish is a plus

Why work at Asphalion?

• Homeoffice, hybrid, or remote work options (anywhere in Spain)
• Variety of projects and new challenges
• Training and personal development programs
• Inclusive, high-performance environment built around Passion, Flexibility, Commitment, Quality, and Camaraderie
• Multinational team with over 15 nationalities
• Well-being programs addressing physical, psychological, and emotional health

Our commitment to diversity and inclusion as an Equal Opportunity Employer.

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