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 at national and international levels, including EU, US, CH, and RoW.
* Pricing and Reimbursement
* Requesting approvals from Health Authorities
* Adapting documentation to comply with Transparency Policy 0070
* Providing Strategic Regulatory Advice
* Reviewing promotional materials, packaging, and labelling
* Leading and managing regulatory projects to ensure timely and successful completion
Requirements:
* At least 4 years of experience in Regulatory Affairs within Pharma departments
* Academic Degree in Life Sciences
* Advanced proficiency in IT, especially MS Office
* Proactive, good communicator, accurate, and detail-oriented
Why work at Asphalion?
* Permanent contract
* Home office & Hybrid or Remote Model (Location flexible within Spain)
* Variety of projects, new challenges, and learning opportunities
* Training and personal development programs
* Inclusive, high-performance work environment fostering skill development and career growth
* Company culture centered on Passion, Flexibility, Commitment, Quality & Companionship
* International team with over 15 nationalities
* Well-being programs covering physical, psychological, and emotional health
* Internal activities & RSC initiatives
Note: This job posting is active and accepting applications.
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