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Regulatory Labelling Manager

UK   •  £50 - £65 per hour  •  Contract/Temporary, Full time

Brief Description:
The Senior Manager, Regulatory Affairs Labelling Operations will be responsible for regulatory support (both technical and operational) in product labelling. This position reports to the Associate Director, Labelling Operations and will be responsible for the creation and maintenance of regulatory text within printed labelling materials throughout the product lifecycle, with primary focus on packaging and artwork for products marketed globally. 
Essential Functions

  • Maintain controlled records for historical, current, and ending labelling changes, and communicate labelling changes to stakeholders at the time of implementation
  • Represent Labelling function within change control management of printed materials
  • Support assigned team(s) by leading activities to ensure timely and compliant implementation of printed labelling materials (for both new commercial products and because of labelling variations and regulatory filing activities from a labelling perspective)
  • Manage collaborative and solution-focused communication among all stakeholders
  • Support the process for linguistic review and translation of label content
  • Maintain a current awareness of evolving regulations, codes of practice and policy issues affecting the pharmaceutical/biologics industry in relation to product labelling. Interpret and communicate health authority perspectives to relevant stakeholders, and recommend policy and/or process changes as needed.
  • Develop and provide metrics and reports related to labelling operational processes and systems to leadership and key stakeholders, as required

Required Knowledge, Skills, and Abilities

  • Experience in the pharmaceutical industry, with direct experience in Global Labelling or in other regulatory affairs function(s).
  • Proven experience in regulatory affairs, with particular focus on labelling. Experience associated with global product labelling regulations strongly desired.
  • Strong judgement and decision-making skills.
  • Excellent verbal and written communication skills and collaborative interpersonal skills.
  • Ability to review regulatory labelling documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies.

Required/Preferred Education and Licences

  • Bachelor?s degree required (Scientific discipline preferred) (or equivalent industry related experience)

Please contact Fandi Hatib on 01727817600 or fhatib@achieva.co.uk

  • Agency: Achieva Group Limited
  • Contact: Fandi Hatib
  • Phone: +44 (0)1727 811 634
  • Reference: 32614
  • Updated: 19th November 2021
  • Expires: 17th December 2021

Achieva Group Limited

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