Asphalion is growing and we are looking for a Regulatory Affairs Senior 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:
· +4 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