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regulatory Labeling Lead

regulatory Labeling Lead

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regulatory Labeling Lead

  • Location:


  • Sector:

    Regulatory Affairs

  • Contact:

    Glen Fairbrother

  • Salary:


  • Job type:


  • Contact email:

  • Job ref:


  • Published:

    5 days ago

  • Duration:

    12 Months +

  • Startdate:


My client needs several The Global Labeling Leads who will have responsibility for the initial creation and relevant updates to labeling documents, as well as guide the labeling team to develop and maintain Core Data Sheets (CDS), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labeling Documents.

You will need to be knowledgeable on key labeling requirements worldwide, in order to ensure that CDS/CSI updates may be implemented globally. You will also advise the Labeling Team on the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text.

The GLL provides project management to the Labeling Team throughout the entire process, from the decision to update a CDS/CSI/USPI/SPC through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements.

Experience an key attributes needed.

· Hands on registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs (Human Medicinal Products); Perspective from HQ, Country office and/or Regional Regulatory Strategy (at a global/multi-national pharmaceutical environment)
· Proven understanding of the dynamics and purpose of company Core Data Sheets (CDS), Core Safety Information (CSI); experiences of review and implications of the CDS/CSI an advantage.
· Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment and practical management of associated impacts.
· Demonstrated ability to interpret and apply global and local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages.
· Knowledge of global/regional regulatory guidelines and requirements is important.
· Demonstrated project management skills and attention to detail required.
If you are available, have the skills and experience required, please call me for more details on the duties / opportunity and client.