Regulatory Affairs Officer

Employer
Invenia Resourcing
Location
Tregonhawke, UK
Salary
Competitive
Closing date
14 Oct 2020

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Sector
Healthcare
Contract Type
Permanent
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Role:

An opportunity has arisen for a Regulatory Affairs Officer with an international pharmaceutical company located in London. This role reports directly into the Head of Regulatory Affairs UK.



Key Responsibilities:
  • Coordinate and prepare MA, variation applications for submission via National or European procedures.
  • Provide pharmaceutical, analytical and other technical information to affiliates, independent associated companies to assist with the registration and maintenance activities of existing MAs.
  • With appropriate support, plan responses to questions from Regulatory agencies during MA applications, MA renewals and variations.
  • Provide responses to regulatory questions relating to the group companies' products registered or undergoing registration.
  • Assist with the maintenance of all MA's with appropriate support.
  • Learn and be aware the current legislation, guidelines and other relevant technical and scientific information appropriate for the role.
  • Maintain records of tasks and registered product information in the internal regulatory databases.
  • Take personal responsibility for representing the Department both internally and externally in own area of expertise.
  • Take responsibility for decision making within area of influence.



Skills & Experience Required:
  • Master's in pharmacy is preferred although any science graduate will be considered
  • 2-5 years of experience within the pharmaceutical industry in disciplines such as quality assurance, pharmacovigilance, regulatory with at least 2 years in Regulatory Affairs.
  • Key skills required are;
  • Diligence
  • Functional knowledge (UK Regulatory)
  • Good communication
  • Team player
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