Senior Regulatory Affairs Officer

hace 1 mes

Madrid, España Trium Clinical Consulting Nv A tiempo completo

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 inRegulatory 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 ofSpanish legal regulations on promotional and non-promotional materialsis a mustYou have expertise inICH guidelinesand registration dossier, CTD format.You have developedProject Management roles .You have expertise in lifecycle management.You have expertise inprice & reimbursement .You have expertise in regulatory submissions.And if you have expertise in ISO IDMP... is a plusWho 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 bothclient and results oriented .You have good analytical skills, attention to detail and ability to manage multiple tasks and priorities at the same time.Atrue QbD'ercan 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 anattractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.Join us to build asustainable career, where job security is ensured, and lasting, meaningful connections are formed.As we're aknowledge-based company, you're guaranteed to embark on a continuous journey of learning and development.Be part of our global success story.
As anaward-winning companywe value everyone's contribution and celebrate achievements together.Ourpromiseto you:As anambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.Moreover, we aim to create ajoyful communitywhere 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 inP artnership, going for theE xtra mile toG et things doneInterested?Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family#J-18808-Ljbffr

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