Regulatory Affairs Project Coordinator

  • Salary: Competitive
  • REF Number: 00030010
  • 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 Affairs Project Coordinator 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 Affairs Project Coordinator will be to:

  • Coordinate tech transfer and new product launches and request and chase requested documents from formulators, manufacturers and suppliers.
  • Order active Pharmaceutical Ingredient, innovator samples and send to formulators or manufacturers for validation batches.
  • Organise meetings between various departments and external meetings as well as writing and distributing minutes of meetings and tracking outstanding issues.

Further responsibilities will include:

  • Liaising with contract manufacturers and Quality Control for completion of allocated projects.
  • Preparing documents for Regulatory Variations and Quality modules, check documentation meets NEEs requirements for variation and submission and proof reading of artworks.
  • Support the department in the preparation for inspections and carry out general administration work related to regulatory activities and manage 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:

  • Previous experience of working in a regulatory department with experience of working in coordinating technology transfer of products and project coordination and an understanding of the QA and QC department's activities.
  • Extremely organised with a high level of accuracy and strong IT skills.
  • Excellent communication skills with the ability to grasp new concepts quickly and work under pressure.

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 CL30010 in all correspondence.

We'll store this in session so if you're applying for mulltiple jobs today so you can use this as a base.