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Senior Regulatory Affairs Officer

Senior Regulatory Affairs Officer

TRIUM Clinical Consulting NVPozuelo de Alarcón, Comunidad de Madrid, Spain
Hace más de 30 días
Descripción del trabajo

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 : 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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