Regulatory Labelling Consultant - Hertford, United Kingdom - Cpl Life Sciences

Tom O´Connor

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Tom O´Connor

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Description

Reference Number:

JO
Regulatory Labelling Consultant


Rate:
Negotiable


Job Type:
Contract


Location:
Hertford

Regulatory Labelling Consultant

6-12 Month initial contract

Offering up to £75.00 Per Hour PAYE DOE

Supporting South Africa/ Africa affiliates

Flexible working, 2 days per month required onsite, Hertfordshire based

ASAP Start

Job Responsibilities include;

  • Point of Contact to Global Labelling Team regarding countries/licenses under her/his responsibility
  • Ensure local labelling text is prepared right first time and ontime according to agreed company procedures and objectives.
  • Support regional labelling team members with health authority questions, requests for further information, preparation, and review of labelling documents prior to submission.
  • Advise Global Labelling Hub and Global Compliance Director regarding any deficiencies or issues.
  • Ensure that supportive documents, not limited to Core Data Sheet or other Reference Label such as USPI, SmPC are obtained in a timely manner to the countries according to local legislation.
  • Eligibility to live and work in the United Kingdom
  • Life Sciences Degree of the equivalent
  • Global Labelling and Regulatory experience.
  • Regulatory experience working with Regional Heath Authorities and indepth Regional Labelling knowledge
  • Highly developed interpersonal, presentation and communication skills with advanced local languages: Afrikaans, French / Arabic and English language capability.
  • Ability to provide innovative approaches to product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations.
  • Understand EU/ US regulatory requirements.

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