Regulatory Affairs Officer

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.

We offer you:

️Permanent contract.

Flexible working schedule - Friday until 15.30h.

Homeoffice, Hybrid or Remote Model (Madrid or Barcelona based)

️ 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 Activities

Equal Opportunity Employer