Regulatory Affairs Officer

  • Salary: Competitive
  • REF Number: 00030516
  • Consultant: Oliver Care
  • Contact: 01438 743047
  • Date Published: 31.07.2014
  • Closed Date: 24.08.2015
  • Sector: Non-Specific
  • Location: South East
  • Discipline: Regulatory Affairs

Oliver Care is recruiting for a Regulatory Affairs 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 the role will be to:

  • Execute global regulatory development and registration plans supporting commercialisation pertaining to the Europe/intercontinental region.
  • Achieve successful, quality Marketing Authorisations for the European Union and draw up regulatory dossiers according to regulatory standards.-Contribute to the drafting and implementation of the regulatory strategy for specific projects ensuring your region is adequately reflected.

Further responsibilities will include:

  • Supervising critical and constructive review of regulatory dossiers (MAA, CTA, etc.) and ensuring quality authoring of core-administrative parts of submissions.
  • Define content of regulatory submission dossiers, manage European Marketing Authorisation procedures (CP, DCP and MRP) or coordinate national/intercontinental procedures with support from RPMs and Local Regulatory Affairs.
  • Coordinate regulatory agencies consultations and ensure timely dissemination of questions from authorities to the relevant functions and stakeholders, and the coordination of related responses.

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

  • Educated to degree level in a scientific discipline.
  • Considerable experience in Regulatory Affairs and knowledge of regulatory procedures.
  • Excellent written and verbal communication skills.

This is an excellent opportunity to join a global speciality-driven pharmaceutical company with innovative Research and Development.

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 CL30516 in all correspondence.

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