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Regulatory Labelling Specialist

Website Achieva Group Limited

As part of the Global Labelling Strategy and Compliance team, and under the supervision of the LPM management, you will work with the Labeling Process Management team to manage Labeling Process Management activities.

Key Activities:
 

  • Support labelling activities associated with legal entity manufacturing change.
  • Collaborate with Local Affiliates, along with Regional Regulatory Affairs and Operations colleagues, to plan and implement label changes, ensuring compliance with labeling processes.
  • Process and system support.
  • Provide artwork source text and process support as necessary.
  • Participate in Labelling Submissions meetings to provide input on labelling processes.
  • Provide regional operational support for labelling.

Knowledge and Skills:

  • Previous experience working in industry in support of Global Labelling, Regulatory.
  • Works well independently and within teams
  • Use of document management tools
  • Ability to develop relationships and work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect
  • Time and project management skills
  • Ability to take initiative and drive results
  • Tolerance for ambiguity
  • Proficiency in anticipating and resolving problems
  • Oral and written communication and presentation skills
  • Relationship management

Education & Experience (Preferred):

  • Degree in pharmaceuticals, natural science or medicine
  • Previous experience working in industry in support of global labelling
  • Project Management
  • Fluent in English (oral and written)

For further details, please contact Tim Barratt on +44(0)1727 817626 or email tbarratt@achieva.co.uk

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