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Regulatory Affairs Officer
ASPHALIONgijón, EspañaHace 6 días
Descripción del trabajoAt least 2 years of experience in Regulatory Affairs within Pharma departments. Fluent in English (C1) and Spanish. Academic degree in Life Sciences. Advanced IT skills, especially MS Office. Proactive, good communication skills, accurate, and detail-oriented. Home office, hybrid, or remote work model (located anywhere in Spain). Variety of projects, new challenges, and experiences. Training and personal development programs. A professional, inclusive, and high-performance environment to develop your skills and grow your career. Company culture centered on Passion, Flexibility, Commitment, Quality, and Camaraderie. Multinational team with over 15 nationalities. Well-being programs supporting physical, psychological, and emotional health. Seniority level : Associate Employment type : Full-time Job function : Management Industry : Pharmaceutical Manufacturing
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Direct message the job poster from ASPHALION.
Asphalion is growing, and we are looking for a Regulatory Affairs Officer with experience in the pharmaceutical industry. We seek someone who loves new challenges, enjoys working in an international environment, and wants to grow with us!
Main responsibilities :
- Submission of MAA, variations, renewals, and procedures worldwide, including EU, US, CH, and RoW.
- Pricing and Reimbursement.
- Requesting information from Health Authorities.
- Adapting documentation to the Transparency Policy 0070.
- Reviewing promotional materials, packaging, and labelling.
- Leading and managing regulatory projects to ensure timely and successful execution.
Requirements :
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Regulatory Officer • gijón, España
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