Regulatory Affairs Senior Officer

Asphalion is growing, and we are looking for a Regulatory Affairs Senior 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 :

• Submitting MAA, variations, renewals, and procedures both nationally and worldwide, including EU, US, CH, and RoW.
• Managing Pricing and Reimbursement processes.
• Communicating with Health Authorities.
• Adapting documentation to the Transparency Policy 0070.
• Providing Strategic Regulatory Advice.
• Reviewing promotional materials, packaging, and labelling.
• Leading and managing regulatory projects to ensure timely and successful execution.

Requirements :

Why work at Asphalion? We offer a permanent contract, flexible working hours (including Fridays until 15 : 30), home office, and hybrid or remote work options. You can be located anywhere in Spain! Enjoy a variety of projects, new challenges, and opportunities for personal development, including training and English lessons. Our inclusive, high-performance environment fosters growth and skill development. We pride ourselves on a company culture centered around Passion, Flexibility, Commitment, Quality, and Camaraderie. Join a dynamic team with colleagues from over 15 nationalities. We prioritize employee well-being through comprehensive physical, psychological, and emotional support programs, along with internal activities and RSC initiatives. We are an Equal Opportunity Employer.

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