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Associate Director, Global Labelling – Oxford – Permanent

Nicholas Howard are delighted to be recruiting for a new and exciting role as an Associate Director, Global Labelling.

Based in Oxford, the Associate Director Regulatory Affairs Labelling will be responsible for regulatory support (both technical and operational) in the area of product labelling. This position reports to the Head of Global Labelling and will be responsible for key functions including creating, updating and maintaining labelling documents throughout the product lifecycle, with primary focus on Company Core Data Sheets and products marketed globally. The candidate will help maintain controlled records for historical labelling changes, and communicate labelling changes to stakeholders at the time of implementation. As needed, the candidate will also help to implement process improvement changes to increase the efficiency and effectiveness of the label review process. This position will interact cross-functionally with members of commercial, legal, safety, medical, and others.

Essential Functions:

  • Maintain expertise regarding key labelling requirements worldwide and stay current with labelling guidelines and regulations as they pertain to the development / maintenance of labelling and advise key stakeholders on the application of these labelling principles.
  • Maintain controlled records for historical, current, and ending labelling changes, and communicate labelling changes to stakeholders at the time of implementation.
  • Manage quality control over entire labelling process and management of revisions, including assigning / tracking projects, workflow execution, and issue resolution.
  • Under the direction of the Head of Global Labelling, assist in implementing process improvements to increase the efficiency and effectiveness of the label review process.
  • Work closely with Regulatory Affairs colleagues and Supply chain colleagues.
  • Provide project management to the Labelling Team throughout the entire process, from the decision to update a CCDS / USPI / SPC through notification to stakeholders, to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements.
  • Responsible for proofreading and departmental QC work.
  • Lead the development of CCDS, package inserts and equivalents and their associated Patient Labelling Documents.
  • When developing new labels, research the content of other labels in the same therapeutic class, including competitor labelling, to help guide the team in developing labelling text, including contingency strategy development for negotiation with regulatory authorities.
  • Support the Head of Global Labelling in providing development and guidance to Labelling Managers and Senior Labelling Managers.
  • As assigned, provide leadership to various process improvement projects.

Required Knowledge, Skills, and Abilities:

  • Experience associated with global product labelling regulations strongly desired.
  • Strong judgment and decision making skills.
  • Excellent written and verbal communication skills.
  • Ability to review regulatory labelling documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies.
  • Must be able to work successfully within a team / partnership environment and as an individual contributor, with a high level of professionalism.
  • Ability to interact effectively with all levels / roles of project team members.
  • Up to approximately 15% travel.

Required / Preferred Education and Licenses:

  • S / B.A. (or equivalent in industry related experience) preferred.
  • Proven experience in regulatory affairs with particular focus on labelling.

To be considered for this position please apply below.