Talent.com
Esta oferta de trabajo no está disponible en tu país.
Regulatory Affairs Senior Officer - Medical Writer

Regulatory Affairs Senior Officer - Medical Writer

buscojobs Españagijón, España
Hace 6 días
Descripción del trabajo

We are looking for a Medical Writer – Regulatory Affairs Senior Officer for our team of development, strategy, and scientific writing experts. Someone who loves science and wants to leverage their experience in a new, challenging professional role.

Main Responsibilities :

  • Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD, IB).
  • Preparing eCTD dossier clinical / nonclinical documents (Module 2).
  • Designing regulatory roadmaps.
  • Developing regulatory strategies for MAA.
  • Client and partner management : defining milestones, planning and executing tasks, managing timelines, and project reporting.
  • Liaising with health authorities for drug development procedures.
  • Managing submissions and applications through portals (CTIS, IRIS, etc.).

Requirements :

  • Educational background in scientific / biomedical fields.
  • Minimum of 3 years of experience in regulatory writing within the pharma sector, or in a spin-off / start-up environment.
  • 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 schedule, including Fridays until 15 : 30, and options for home office, hybrid, or remote work (anywhere in Spain).
  • Variety of projects, new challenges, and opportunities for growth.
  • Training and personal development programs, including English lessons.
  • Inclusive, high-performance work environment focused on skills development and career growth.
  • Culture built around passion, flexibility, commitment, quality, and companionship.
  • Multinational team with employees from over 15 nationalities.
  • Well-being programs covering physical, psychological, and emotional health, along with internal activities and RSC initiatives.
  • Equal Opportunity Employer.

    • J-18808-Ljbffr

    Crear una alerta de empleo para esta búsqueda

    Senior Medical Writer • gijón, España