Regulatory Executive

  • Salary: Competitive
  • REF Number: 00032275
  • Consultant: Mary Tilston
  • Contact: 01438 768717
  • Date Published: 18.03.2015
  • Closed Date: 24.08.2015
  • Sector: Non-Specific
  • Location:
  • Discipline: Regulatory Affairs

Mary Tilston at CK Clinical is recruiting for a Regulatory Executive to join a company in the pharmaceutical industry at their site based in Middlesex on a contract basis.

The main purpose of the role will be to

  • Prepare high quality, detailed CMC regulatory documents using varied information sources and liaise closely with other personnel and groups to ensure the accuracy of such documents and that ongoing projects are captured in these documents and changes recorded.
  • Provide CMC regulatory support for global sourcing initiatives.
  • Develop regulatory strategy for sourcing changes on the API and Drug Product.

Further responsibilities will include:

  • Preparing regulatory dossiers to support source changes and creating and maintaining regulatory plans.
  • Providing regulatory advice to colleagues in the manufacturing organisation and responding to agency questions as required.
  • Interfacing with other regulatory departments within Global Regulatory Affairs and Local Operating Companies.

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 with significant previous experience in Regulatory Affairs (CMC) and a strong CMC background (chemistry or pharmacy).
  • Emerging Markets experience with strong experience of CTD authoring and change control and EU variation experience.
  • Experience of managing multiple projects.

This is an excellent opportunity to join a global leader in the pharmaceutical industry.

For more information or to apply for this position, please contact Mary Tilston on 01438 768717 or email 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 CL32275 in all correspondence.

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