Regulatory Affairs Senior Officer - Medical Writer

ASPHALION; Santander; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

ASPHALION, a leading company in regulatory affairs, is seeking a Medical Writer – Regulatory Affairs Senior Officer. This role involves writing regulatory documents, managing client relationships, and strategizing for drug development. Join a diverse and supportive environment with flexible work options and a focus on professional growth.

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.

Responsabilidades

• Writing regulatory documents to support drug development.
• Designing regulatory roadmaps and developing regulatory strategies for MAA.
• Liaising with health authorities for drug development procedures.

Conocimientos

Client-oriented communication

Proactive mindset

Strong 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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