Eu Labelling - Anderlecht, België - UCB S.A.

UCB S.A.
UCB S.A.
Geverifieerd bedrijf
Anderlecht, België

5 dagen geleden

Sophie Dubois

Geplaatst door:

Sophie Dubois

beBee Recruiter
Beschrijving

Make your mark for patients
We are looking for a
European Labelling & Promotional Scientist to join us in our
Regulatory team, based in our Brussels, Belgium office


About the role
Provides European Labelling & Promotional Regulatory expertise across a Therapeutic business unit. Delivers strategic and operational regulatory input and guidance to the cross functional teams.


Who you'll work with


You will report into the EU Labelling and Promotion Lead and work closely with the European Regulatory and the European Business.


What you'll do

  • Creation, update and maintenance of the EU Product Information in line with the CCDS, Agency RTQ, and most uptodate labelling requirements and labelling template in the appropriate ECMS and according to SOPs
  • If applicable, for assigned Early development assets, deliver competitive labelling searches and contributes to the TCLP
  • Key point of contact for the EU Product Information (Annex I SmPC, Annex II, Annex IIIA Label and Annex IIIB PIL, IFU) for internal (GRA + strategic Partners in Country) and external stakeholders (medical, legal, commercial, safety, quality and be the EU labelling representative in team meetings (EU RST, Global RST, Product Labelling Team,). Lead Reviews, Round Tables, Approvals for the EU Product Information (SmPC, Label, PIL, IFU) in the appropriate system and according to SOP
  • Delivers operational excellence for all labelling activities according to timelines, such as appropriate tracking of the EU Product Information (SmPC, Label, PIL) in the appropriate system and according to SOP
  • Lead the Readability Testing (selection of service provider, management of agreement, review of questionnaire, availability of mockup, review and submission of final report)
  • Linguistic review process: Lead with the LR Coordinator the Linguistic review according to SOP, assist with the preparation of the Closing Sequence and ensure communication of HA approval label to internal and external stakeholders according to SOP
I
nterested? For this position you'll need the following education, experience and skills:

  • Bachelor's degree
  • Build effective partnerships identifies opportunities and takes actions to build effective relationships within team and with other areas
  • Influencing skills through well thought through rationale and effective communication skills, able to influence key decisions


  • Flexibility and adaptability

  • Decides what to do based on the situation. Changes behaviour or approach to fit the situation or the person. Works effectively in ambiguous situations
  • Communication skills knows when and how to communicate, using strong interpersonal skills and written communications when appropriate
Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you


About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.


Why work for us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients.

We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work.

We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees or our planet.

Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.


Learn more about sustainability at UCB and how it is integrated into our business approach.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
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