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Labelling Consultant

  1. Home Counties
Hertfordshire
  1. Contract
Competitive
  1. Drug Safety / Pharmacovigilance
14-09-2023
32003

This vacancy has now expired

Labelling Consultant – Pharmaceuticals – Hertfordshire

Are you looking for the opportunity to work alongside a global pharmaceutical organisation? Our esteemed client is looking for a Labelling Consultant to join their team in their existing manufacturing facility in Hertfordshire.

The facility is a responsible for tablet manufacturing (OSD) and secondary packaging (blister packing and bottle primarily for tablets and capsules), and our client is looking for a Labelling Consultant to help maintain manufacturing operations.

Responsibilities:
  • Awareness of and adherence with Labelling requirements including, but not limited to, relevant internal and external legislation, regulations, standard operating procedures, guidance and templates etc.
  • Provide Labeling strategy (in close collaboration with SME for pre-/clinical development/program, definition of indication, posology etc) where applicable.
  • Develop and establish territorial Label documents for product, e.g. Monograph, SmPC, PI or RSI, as appropriate
  • Review of proposed, or approved, PI texts for compliance with relevant mandated safety triggers, CCDS or Brand Leader (or other Legal Basis Reference Product). As required, this includes locating and confirming the validity of such information.
  • Authoring of the SmPC, confirming compliance with mandated safety triggers, Brand Leader, CMC and relevant Labelling requirements.
  • Authoring of the Package Leaflet (PL) and Labelling, ensuring consistency with the proposed, or approved, SmPC, relevant safety triggers and Labelling requirements.
Required skills:
  • Bachelor’s degree in Science, Medicine or Pharmacy, or Master's Degree, PharmD, or PhD in Science, Medicine, or Pharmacy.
  • 4 years global Labelling and Labelling development experience, preferably in Generics.
  • Highly developed interpersonal, presentation and communication skills.
  • Fluent in speaking, comprehending, reading and writing English.
  • Ability to provide innovative approaches/recommendations to product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations.
  • Understand EU/ US regulatory requirements.
  • The ability to influence effectively in a matrixed, cross functional team environment.
If this role is of interest, please apply now.

The candidate must have the rights to work in the location stated in the job advert.

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