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