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 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 client and partner relationships: 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 in scientific or biomedical fields
• Minimum of 3 years of experience in regulatory writing within the pharma sector or spin-offs/startups
• Strong knowledge of regulatory affairs
• Excellent client-oriented communication skills and a proactive mindset
• Advanced proficiency in IT tools (MS Office Suite)
• 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 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 around Passion, Flexibility, Commitment, Quality, and Camaraderie
• Multinational environment with employees from over 15 nationalities
• Employee well-being programs, including physical, psychological, and emotional support
• Internal activities and corporate social responsibility initiatives
• Equal Opportunity Employer