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Head of Labelling

Location: 

Slough, Berkshire, United Kingdom

Job Function:  Regulatory Affairs
Job ID:  66277

Head of Labelling

 

To strengthen our Global Regulatory team based in our UK head Office in Slough, we are looking for a talented individual to fill the position of: Head of Labelling.   

 

As the Head of Labelling you will Ensure business continuity is maintained whilst looking for efficiencies and innovation.

 

You like to work in an environment where you can:

  • Be responsible for the Global Labeling function, combining knowledge of scientific, regulatory and business issues to ensure compliance with regulatory requirements and UCB standards.
  • Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
  • As a leader both internally and externally, contributing to cross-functional initiatives and influencing the field as applicable.
  • Monitor and participate in the external environment related to industry labeling trends and emerging technologies.

 

You will contribute by:

  • Oversight of the creation and maintenance of product labeling worldwide through CCDS processes.
  • Leading Global Labeling team to ensure CCDS/labeling documents are prepared and executed in accordance with applicable regulations and company position.
  • Overseeing regulatory guidance provided to ensure compliance with labeling regulations.
  • Establishing and maintaining a process for ensuring compliance from a labeling perspective, based on internal and external standards.
  • Managing personnel within group to ensure coverage for all therapeutic areas and products.
  • Understands and interprets complex scientific issues as related to regulatory requirements and labeling strategy. Partners with key internal and external stakeholders to resolve issues.
  • Ensuring that key stakeholders and line management are informed of key labeling issues/risks with mitigation plans.
  • Developing strategy for efficient and appropriate Global Labeling review and plays a key role in life cycle management strategy and implementation.
  • Identifying trends in labeling-related regulatory authority compliance enforcement, policies and procedures; incorporates into regulatory decisions and strategy.
  • Overseeing an assigned portfolio of projects or highly complex projects.
  • Demonstrating the ability to anticipate risks and for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.

 

Interested? For this position you’ll need the following education, experience and skills:

  • BSc degree or equivalent, advanced scientific degree (MSc, PhD, or PharmD) preferred.
  • Extensive experience of the pharmaceutical industry; inclusive several years regulatory experience.
  • Knowledge of global standards and regulations related to CCDS and Product Labeling (US PI and EU SmPC experience required, other regional labels also preferred).
  • Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.
  • Demonstrates acceptable skills with increasing independence in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
  • Able to bring working teams together for common objectives.

 

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

 

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.


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