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 :

We offer you : Permanent contract.

Flexible working schedule - Friday until 15.30h.

Homeoffice, Hybrid or Remote Model (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

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