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Job Details

Head of Regulatory Services Unit

Company: CROMSOURCE
Location: United Kingdom
Reference: HQ00001322
Closing Date: 25 Jun 18
Type: Permanent
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

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Job Summary:

Job Title: Head of Regulatory Services Unit Location: United Kingdom Schedule: Full time, permanent   CROMSOURCE, an international, full service CRO, is looking for a Head of Regulatory Affairs to join our team, who will be responsible for the growth objectives, revenue and added value of the department. The function will also ensure the delivery of regulatory services with high quality standards to CROMSOURCE clients   Main Job Tasks and Responsibilities Defines new...

Requirements:

Job Title: Head of Regulatory Services Unit

Location: United Kingdom

Schedule: Full time, permanent

CROMSOURCE, an international, full service CRO, is looking for a Head of Regulatory Affairs to join our team, who will be responsible for the growth objectives, revenue and added value of the department. The function will also ensure the delivery of regulatory services with high quality standards to CROMSOURCE clients

Main Job Tasks and Responsibilities

  • Defines new strategies for additional business growth of the Regulatory Services Unit
  • Defines new service offerings adapted to the market evolution and customer demand
  • Maintains and improves customer satisfaction of regulatory services
  • Maintains relationships with clients
  • Ensures an optimal development of direct reports: plans, defines (in terms of SMART objectives) and follows up (one on one meetings, coaching meetings, and appraisal meetings) the Unit staff to ensure good performance management
  • Manages the workload of the staff unit
  • Oversees the planning of project activities and projects budget
  • Ensures scientific and personal development of staff unit as specialists in their area
  • Defines the training program of the staff unit
  • Ensures good cooperation of regulatory services with other departments
  • Provides high level problem solving to ensure client satisfaction and repeated business
  • Supports business development in the processing of request for proposals ensuring correct operational input
  • Ensures writing and review of Regulatory Services SOPs and Working Instructions in order to implement compliant regulatory processes

Education and Experience

  • University Degree in scientific, medical or paramedical disciplines
  • Significant experience within Regulatory Affairs
  • Excellent knowledge of ISO 9001, ICH-GCP, MDD, AIMDD, ISO EN 14155, relevant MEDDEVs and EUCTD and relevant International and national regulations
  • Fluent in English
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
  • Willingness to travel

CROMSOURCE offers

As a UK employee you will be entitled to the following benefits in addition to your competitive salary:

  • 25 days annual leave + 8 bank holidays
  • Pension contributions of 5%
  • Life assurance
  • Child care vouchers
  • Eye care vouchers

If you would like to be considered for this exciting opportunity pleased send your CV directly to myna.yeboah@cromsource.com

CROMSOURCE is a family owned international, full-service Contract Research Organization who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Keywords

Regulatory Affairs Manager Head of Regulatory Affairs Regulatory Affairs Project Manager

Regulatory Affairs Manager

Apply for this job: Head of Regulatory Services Unit

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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