We are looking for a Medical Writer Expert – Regulatory Affairs to join our team of development, strategy, and scientific writing specialists. The ideal candidate loves science and seeks a new professional challenge.
Main responsibilities:
1. Ensure the timely and accurate execution of projects according to defined timelines.
2. Write regulatory documents to support drug development (SA, PIP, ODD, IMPD, IB).
3. Prepare eCTD Dossier clinical/nonclinical documents (Module 2).
4. Design regulatory roadmaps.
5. Develop regulatory strategies for MAA.
6. Manage client and partner relationships:
define milestones, plan and execute tasks, manage timelines, and report on projects.
7. Liaise with health authorities for drug development procedures.
8. Handle submission and management of applications through portals (e.G., CTIS, IRIS).
Requirements:
* Educational background in scientific or biomedical fields.
* Minimum of 8-10 years of experience in regulatory writing within the pharma sector, or spin-off/start-up environments.
* Strong knowledge of regulatory affairs.
* Excellent client-oriented communication skills and a proactive mindset.
* 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.
* Flexible working schedule, including Fridays until 15:
30.
* Home office, hybrid, or remote work options (location in Spain not required).
* Variety of projects and new challenges.
* Training and personal development programs.
* English lessons.
* Inclusive, high-performance work environment focused on growth.
* Company culture centered on Passion, Flexibility, Commitment, Quality, and Camaraderie.
* Multinational environment with employees from over 15 nationalities.
For more details, visit the original job posting on Kit Empleo:
here.
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