Regulatory Affairs Senior Officer - Medical Writer

Medical Writer – Regulatory Affairs Senior Officer

Join our team of development, strategy, and scientific writing experts. We are looking for someone who loves science and wants to leverage their experience in a new, challenging professional step.

Main responsibilities: The Medical Writer will be responsible for 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. Formulating regulatory strategies for MAA
5. Managing clients and partners: defining milestones, planning and executing tasks, managing timelines, and reporting
6. Liaising with health authorities for drug development procedures
7. Submitting and managing applications through portals (CTIS, IRIS, etc.)

Requirements:

• Educational Background: Scientific/biomedical background
• Experience: Minimum of 3 years in a similar regulatory writing role within the pharma sector, or spin-offs/startups
• Skills and Competencies: Strong regulatory affairs knowledge, excellent client 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
• Flexible working schedule - until Friday 15:30
• Home office & hybrid or remote model
• Location: Anywhere in Spain
• Variety of projects, new challenges, and experiences
• Training and personal development programs, including English lessons
• Inclusive, high-performance work environment to develop your skills and grow your career
• Company culture centered around Passion, Flexibility, Commitment, Quality & Companionship
• Diverse environment with employees from over 15 nationalities
• Employee well-being programs: physical, psychological, and emotional support
• Internal activities & RSC initiatives

Position: Senior Medical Writer

Location: Seville, Andalusia, Spain