QbD Groupteam offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, ATMP and Medical Devices/IVD. We are always looking for the next QbD'er in Regulatory Affairs.What do we expect from you as a Senior Regulatory Affairs Officer? You have knowledge of general pharmaceutical legislation and regulations, including GMP. Good knowledge of Spanish legal regulations on promotional and non-promotional materials is a must! You have expertise in ICH guidelines and registration dossier, CTD format. You have developed Project Management roles. You have expertise in lifecycle management. You have expertise in price & reimbursement. You have expertise in regulatory submissions. And if you have expertise in ISO IDMP... is a plus! Who are we looking for? You have a Master degree in Pharma Industry or Regulatory Affairs Management. Minimum of 4 years' experience in the field. You are both client and results oriented. You have good analytical skills, attention to detail and ability to manage multiple tasks and priorities at the same time. A true QbD'er can be recognized by the following qualities: Resilient: Your strong and positive attitude helps you overcome any challenge. Hungry for knowledge: You are always open to learning. No non-sense mentality: you can be straightforward in a respectful way. Innovative: You are constantly looking for new and better solutions. (Not too) serious: your job is serious, but you don't take yourself too seriously. What's in it for you? QbD Group offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations. Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed. As we're a knowledge-based company, you're guaranteed to embark on a continuous journey of learning and development. Be part of our global success story. As an award-winning company we value everyone's contribution and celebrate achievements together. Our promise to you: As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences. Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals. In short … We stand for? JPEG: Joy in Partnership, going for the Extra mile to Get things done! Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!
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