Manager Regulatory Affairs

  • Salary: Competitive
  • REF Number: 00033636
  • Consultant: Oliver Care
  • Contact: 01438 743047
  • Date Published: 24.08.2015
  • Closed Date: 17.02.2016
  • Sector: Non-Specific
  • Location: Home Counties
  • 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 Hertfordshire on a permanent basis.

The main purpose of the role will be:

  • To manage a team including setting objectives, mid-year and end-year reviews and ensure training, development and coaching of team members is in place in order that they meet the team and individual objectives.
  • To support the Director of affiliates by leading the UK team to support or develop strategies for departmental initiatives and ensure the successful roll-out of local and/or regional or global initiatives. Work alongside the managers and groups when relevant, to roll-out the initiatives to ensure timelines are met.
  • To ensure suitable registration packages are prepared and dispatched on-time according to agreed company procedures and objectives.

Further responsibilities will include:

  • Undertaking appropriate action as soon as regulatory assessment timelines are going to differentiate from the planned timelines in consultation with senior management.
  • On request, advising Central Regulatory about regulatory strategy for new products and post-approval submissions for the UK including timelines and national guidelines and interpretations.
  • Advising Senior Management of the status and progress of team projects to meet departmental objectives and timelines, identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience: Bachelor's degree in pharmacy or related field with considerable Regulatory experience. Good knowledge and understanding of EU Regulatory Affairs

This will be an excellent opportunity to join one of the world's largest generics companies and benefits include an annual bonus.

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 the link below to apply online.

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 CL33636 in all correspondence.

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