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Medical Writer – Regulatory Affairs Senior Officer

hace 4 semanas


Murcia, Murcia, España buscojobs España A tiempo completo
Medical Writer – Regulatory Affairs Senior Officer

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.).
Requirements :
  • 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.
Why work at Asphalion?
  • Permanent contract.
  • Home office & hybrid or remote model (located anywhere in Spain).
  • Variety of projects, new challenges, and experiences.
  • Training and personal development programs.
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