QbD Group 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 serious.
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: J oy in P artnership, going for the E xtra mile to G et 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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