Regulatory Affairs Associate/Manager in Cambridge

  • Salary: Competitive
  • REF Number: 00045674
  • Consultant: Hendre Moolman
  • Contact: 01438 842970
  • Date Published: 04.06.2019
  • Sector: Non-Specific
  • Location: Home Counties
  • Discipline: Regulatory Affairs

Hendre Moolman at CK Group is recruiting for a Regulatory Affairs Manager to join a pharmaceutical company at their site based in Cambridge on a contract basis.

The Company:

  • Our client is has very strong core values of mutual respect, honesty, innovation, and commitment that form part of the foundation and framework of the business.
  • They research and develop innovative medications for therapeutic treatments ranging from respiratory diseases, pain, & oncology.

The Location: The role is based at our client's site in Cambridge which is easily commutable from London via car and the modern, light and easy to reach offices are located on the northern side of Cambridge. The offices have ample parking available with plenty of walk ways for lunch time walks.

The Role:

The main purpose of the role will be to:

  • Perform required licence maintenance activities for UK and Irish national MAs, including support for variations, renewals, and licence withdrawals.
  • Maintain product regulatory history through company systems and appropriately archive all regulatory documents and agency communications.
  • Manage the maintenance of SmPC and PIL texts internally and on external websites.

Further responsibilities will include:- Provide operational regulatory support to the UK and Ireland Regulatory Affairs department.

  • Ensuring all local regulatory activities are completed to a high standard in a timely manner in accordance with business priorities.
  • Liaise with outsourced teams and 3rd parties in the compilation and submission of regulatory applications.

Your Background:

  • To succeed in this role, you will come from a Life Science background and have a strong Technical regulatory experience.
  • Good understanding of relevant Regulatory Guidelines and legislation for the UK and Ireland.

For more information or to apply for this position, please contact Hendre Moolman on 0143 842 970 or email hmoolman@ckclinical.co.uk. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group 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 45674 in all correspondence.

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