Shire Regulatory Labeling Operations Specialist in Paddington, United Kingdom

  • Assists Regulatory Labeling Operations Team in preparation, review and quality checks of artwork.

  • Proof-reads all labeling documentation, including company core data sheets, US Prescribing Information, Structured Product Labeling (SPL), EU Summary of Product Characteristics, and other documents as required by GRA Labeling.

  • Quality check (QC) labeling documents against regulatory requirements.

  • Maintenance of and data input to regulatory databases and tracking spreadsheets.

  • Assists with preparation and review of Structured Product Labeling preparation.

  • Assists with provision of approved product information to internal functional areas, including local Affiliates.

  • Raises project issues to manager/RLO leads for resolution and agreement.

  • Collaborate with regulatory team to track labeling milestones.

  • Assists Regulatory Labeling team with ad hoc projects.

Responsibilities

% of Time

70 - Preparation, review, and quality checks of artwork. Proofreading and QC of labeling documentation.

20 - Maintenance of regulatory labeling tracking databases.

10 - Assistance with ad hoc projects as defined by Manager

Education and Experience Requirements

  • Bachelor's degree is preferred. Scientific/health care field preferred, but not required.

  • Relevant / related experience within a pharmaceutical company, CRO or similar organization; or equivalent combination of education and experience.

  • Direct experience with regulatory labeling.

  • Knowledge of EU labelling regulations

  • Project Management experience within labelling, artworks or packaging

  • Knowledge of medical device labeling (preferred, not essential).

Key Skills, Abilities, and Competencies

  • Ability to manage multiple projects.

  • Good communication skills.

  • Proofreading experience.

  • Familiarity of current US and EU labeling regulations and guidances.

  • Understands requirements for implementation.

  • Requires strong attention to detail in reviewing materials.

  • Must be able to multitask.

  • Strong knowledge of MS Word, Excel, PowerPoint

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.