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Medical Writer – Regulatory Affairs Senior Officer
hace 4 semanas
Cartagena
EUR 40.000 - 60.000
We are looking for a Medical Writer – Regulatory Affairs Senior Officer for our team of development, strategy, and scientific writing experts. This role is ideal for someone passionate about science and eager to leverage their experience in a new, challenging professional environment.
Main Responsibilities :- Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD, IB).
- Designing regulatory roadmaps.
- Developing regulatory strategies for MAA.
- Managing client and partner relationships: defining milestones, planning, executing tasks, managing timelines, and project reporting.
- Communicating with health authorities regarding drug development procedures.
- Submitting and managing applications through portals (CTIS, IRIS, etc.).
- Educational Background : Scientific or biomedical background.
- Experience : Minimum of 4 years in a similar regulatory writing role within the pharma sector, or in spin-offs/startups.
- Skills and Competencies : Strong knowledge of regulatory affairs, excellent client-oriented communication skills, proactive mindset.
- Technical Skills : Advanced proficiency in IT tools (MS Office Suite).
- Languages : Fluency in English (C1 or higher) is mandatory; Spanish is a significant advantage.
- Permanent contract.
- Home office & hybrid or remote model (located anywhere in Spain).
- Variety of projects, new challenges, and experiences.
- Training and personal development programs.