Regulatory Affairs Senior Officer - Medical Writer

ASPHALION; Castellón de la Plana; Híbrido; EUR 45.000 - 60.000; Jornada completa

Descripción de la vacante

A prominent company in the pharmaceutical sector seeks a Medical Writer - Regulatory Affairs Senior Officer to join their team focused on scientific writing and regulatory strategies. This role involves writing critical regulatory documents and managing client interactions within a dynamic hybrid work environment. Candidates should possess a scientific degree and relevant experience, with strong knowledge of regulatory affairs and exceptional communication skills.

Servicios

Permanent contract with flexible working hours

Home office & hybrid work options

Training and personal development programs

Well-being programs for employees

Formación

• Minimum 3 years in a similar regulatory writing role.
• Fluency in English (C1 or higher) mandatory; Spanish a significant advantage.

Responsabilidades

• Writing regulatory documents to support drug development.
• Preparing eCTD dossier clinical/nonclinical documents.
• Liaising with health authorities regarding drug development procedures.

Conocimientos

Strong knowledge of regulatory affairs

Client-oriented communication skills

Proactive mindset

Advanced proficiency in IT tools

Educación

Scientific or biomedical degree

Herramientas

MS Office Suite

Descripción del empleo

Medical Writer – Regulatory Affairs Senior Officer

Join our team of development, strategy, and scientific writing experts. We are looking for someone passionate about science who wants to take their experience to a new professional challenge.

Main responsibilities: The Medical Writer will ensure the timely and accurate execution of projects according to defined timelines:

1. Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD, IB)
2. Preparing eCTD dossier clinical/nonclinical documents (Module 2)
3. Designing regulatory roadmaps
4. Developing regulatory strategies for MAA
5. Managing clients and partners: defining milestones, planning, executing tasks, managing timelines, and reporting
6. Liaising with health authorities regarding drug development procedures
7. 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, spin-offs, or startups
• Skills and Competencies: Strong knowledge of regulatory affairs, excellent client-oriented communication skills, proactive mindset, 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 with flexible working hours—Friday until 15:30
• Home office & hybrid or remote work options
• Open to candidates located anywhere in Spain
• Variety of projects, new challenges, and growth opportunities
• Training and personal development programs, including English lessons
• Inclusive, high-performance work environment focused on skills development and career growth
• Company culture centered on Passion, Flexibility, Commitment, Quality & Camaraderie
• Multinational team with employees from over 15 nationalities
• Well-being programs covering physical, psychological, and emotional health
• Internal activities & CSR initiatives
• Equal Opportunity Employer