Senior Associate Regulatory Affairs Labelling

1 month ago

London, United Kingdom Planet Pharma Full time

Job Description

Senior Associate Regulatory Affairs Labelling

London

Freelance (potential to extend)

Job Summary

  • As part of Global Labelling Strategy and Compliance, and under the supervision of the LPM management, the Labeling Process Management, Senior Associate supports the Labeling Process Management team to manage Labeling Process Management activities.

Key Activities

Principal responsibilities include, but are not restricted to:

  • 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)
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