Regulatory Scientist - Immunology
UCB
Anderlecht, Brussels, Belgium
5 dagen geleden

Make your mark for patients.

We’re here because we want to build the future and transform patients’ lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients.

We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?

To strengthen our Global Regulatory function , based in our Brussels office we are looking for a talented individual to fill the position of Regulatory Scientist .

As a Regulatory Scientist you will have the following responsibilities :

  • Prepare and deliver regulatory operational plans for assigned projects / products within a specific region as agreed with the Regulatory Scientist Lead / Manager.
  • Provide strategic and operational regulatory input and guidance in cross-functional teams. Manage quality regulatory submissions to agreed project targets.
  • Work flexibly within and across regions (EU, MENA ) to provide broad operational support to ensure the delivery of product team and business objectives.
  • Assist in development of regulatory standards and SOPs / Workshops
  • Support the Global Regulatory Scientist Lead for the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant UCB procedures and regional / local country regulations.
  • Respect the planning, coordinate preparation and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and / or regional perspective.
  • Liaise proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice
  • Identify potential regulatory risks to the operational plan and propose options to mitigate risks.
  • Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
  • Assume assigned responsibilities for routine and non-routine contact with health authorities and affiliates to support the Global Regulatory Scientist Lead.
  • Interested? For this position you’ll need the following education , experience and skills :

  • Bachelor’s degree
  • Several years hands-on experience in Regulatory Affairs, with knowledge of assigned regional regulatory procedures and legislation for complex therapeutics.
  • Preferably experience within Life Cycle management & development projects.
  • Communication skills knows when and how to communicate, using strong interpersonal skills and written communications when appropriate.
  • Build effective partnerships identifies opportunities and takes actions to build effective relationships within team and with other areas.
  • deze vacature melden
    checkmark

    Thank you for reporting this job!

    Your feedback will help us improve the quality of our services.

    Solliciteren
    Mijn E-mail
    Door op "Doorgaan" te klikken, betekent dit dat je neuvoo toestemming geeft om je gegevens te verwerken en je e-mails met vacatures te sturen, zoals beschreven in neuvoo's -Privacybeleid . Je kunt je toestemming altijd intrekken
    Doorgaan
    Aanvraagformulier