Asphalion is growing and we are looking for a Regulatory Affairs Officer with experience within pharmaceutical industry! Someone who loves to take new challenges, to work in an international environment and who wants to grow with us!
Main responsibilities:
• Submissions of MAA, variations, renewals and procedures national and worldwide, including EU, US, CH, Rest of the World (RoW), etc.
• Pricing and Reimbursement
• Request to Health Authorities
• Due Diligence
• Adapt the documentation to the Transparency Policy 0070
• Strategic Regulatory Advice
• Review of promotional material, packaging & labelling
• Project management: Lead and manage regulatory projects to ensure timely and successful execution of tasks
Requirements:
· +2 years experience in Regulatory Affairs Pharma departments.
· Fluent in English (C1) & Spanish
· Academic Degree in Life Science
· Advanced IT level – (MS Office)
· Proactive, good communication, accurate, detail orientated.
Why working at Asphalion?
🖋️Permanent contract.
📅 Flexible working schedule - Friday until 15.30h.
💻 Homeoffice & Hybrid or Remote Model (You can be located anywhere in Spain!)
⚙️ Wide variety of projects, new challenges and experiences.
↗️ Training and personal development program.
📚English lessons.
🤗 A professional, inclusive and high-performance work environment to develop your skills and grow your career. A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship.
🌍A highly & dynamic working environment with employees from more than 15 nationalities.
🤸🏽Our people and their well-being are our priority: Physical, psychological and emotional well-being programme.
🌳 Internal activities & RSC Activitie
✅ Equal Opportunity Employer