Regulatory Affairs Officer

  • Salary: Competitive
  • REF Number: 00030007
  • Consultant: Oliver Care
  • Contact: 01438 743047
  • Date Published: 16.06.2014
  • Closed Date: 24.08.2015
  • Sector: Non-Specific
  • Location: South East
  • Discipline: Regulatory Affairs

Oliver Care is recruiting for a Regulatory Officer to join a company in the pharmaceutical industry at their site based in the South East on a contract basis.

The main purpose of your role as Regulatory Officer will be to:

  • Ensure the the company's products comply with MHRA regulations and guidelines to ensure licenses are granted and continuously maintained and provide regulatory information, guidance and support to R&D, Commercial, Clinical and Quality functions.
  • Be responsible for the timely management, preparation, submission and follow-up of regulatory initial submissions to competent authorities.
  • Ensure all preparation, submission and follow ups of license variations and approvals are carried out in a timely manner.

Further responsibilities will include:

  • Writing clear, accessible product labels and PILs and specify storage, labelling and packaging requirements.
  • Continuously maintain the quality systems and ensure regulatory procedures and systems are implemented in order to comply with regulatory requirements and agreed quality standards.
  • Undertake and manage the regulatory inspections as well as general administration work related to regulatory activities and managing all external and internal communications.

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

  • Educated to degree level or above in life sciences or a related field.
  • Previous experience of working within the pharmaceutical industry including experience of writing and assessing CMC dossiers, the preparation and submissions of type 1A, 1B and II variations and the submissions of dossiers following DCP, MRP and national procedures.
  • Excellent communication and interpersonal skills.

For more information or to apply for this position, please contact Oliver Care on 01438 743047 or email ocare@ckclinical.co.uk. Alternatively, please click on the link below to apply online now.

CK Clinical is an Equal Opportunities employer and 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 CL30007 in all correspondence.

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