Regulatory Affairs Manager

  • Salary: 50,000
  • REF Number: 00033781
  • Consultant: Oliver Care
  • Contact: 01438 842976
  • Date Published: 11.09.2015
  • Closed Date: 17.02.2016
  • Sector: Non-Specific
  • Location: Buckinghamshire,
  • Discipline: Regulatory Affairs

Oliver Care at CK Clinical is recruiting for a Manager Regulatory Affairs to join a company in the pharmaceutical industry at their site based in Buckinghamshire on a permanent basis.

The main purpose of the role will be:

  • To provide appropriate EU regulatory input to project teams and Global Regulatory Slides via the Global Liaison and Global Regulatory Teams.
  • To be responsible for ensuring effective planning, tracking, archiving of activities, especially submissions, internal memos and key correspondence.
  • To be responsible for ensuring that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development and registration

Further responsibilities will include:

  • Drive and lead regulatory activities in support of lifecycle management and maintenance in the region.
  • Identify compliance risks proactively.
  • Support co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging as required to ensure regulatory compliance.

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

  • Life sciences graduate with sound knowledge of both European pharmaceutical regulations and guidelines and national regulations within the assigned region.
  • Prior relevant experience in pharmaceutical Regulatory .

This is an excellent opportunity to join multi-speciality, global pharmaceutical company that delivers leading, innovative products.

For more information or to apply for this position, please contact Oliver Care on 01438 743 047 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 CL33781 in all correspondence.

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