Regulatory Affairs Officer

  • Salary: Competitive
  • REF Number: 00033769
  • Consultant: Oliver Care
  • Contact: 01438 842 976
  • Date Published: 11.09.2015
  • Closed Date: 17.02.2016
  • Sector: Non-Specific
  • Location: South East
  • Discipline: Regulatory Affairs

Oliver Care at CK Clinical is recruiting for a Regulatory Affairs Officer to join a company in the pharmaceutical industry at their site based in Surrey on a permanent basis.

The main purpose of the role will be to:

  • Develop and maintain a comprehensive understanding of the regulatory environment, including data requirements, relating to marketing authorisations for medicinal products in the UK and Europe and for non-medicinal products.
  • Develop an understanding of the commercial environment in the UK and contribute to the commercial success through product teams.
  • Provide regulatory advice during development, to support life-cycle management and commercial activities.
  • Maintenance of marketing authorisations - establish and maintain the ability to critically review, prepare and submit the necessary documentation to the regulatory authorities, including justifications.

Further responsibilities will include:

  • Responses to enquiries/requests for further information relating to regulatory submissions - establish and maintain the ability to critically review and efficiently prepare and submit the necessary documentation.
  • Support activities to ensure regulatory compliance, identifying, highlighting and resolving issues where necessary.
  • Pro-actively review critical new legislation and guidance documents and disseminate to relevant parties information of importance to the business.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • A degree or professional qualification in science, preferably a life science.
  • Preferably some experience in Regulatory Affairs in the pharmaceutical industry or a related field.

This is an excellent opportunity to join a global pharmaceutical company developing high quality products across the world and it also offers an attractive benefits package.

For more information or to apply for this position, please contact Oliver Care on 01438 842976 or email ocare@ckclinical.co.uk. Alternatively, please click on the link below to apply online now.

CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL33769 in all correspondence.

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