Regulatory Affairs Officer

Highly Competitive
  1. Permanent
  2. Officer /Associate
  3. Belgium
Brussels, Belgium
Posting date: 15 Apr 2020
29070

We are looking for a highly motivated Regulatory Affairs Officer to join a prestigious pharmaceutical company in the UK. The international company specialises in various therapy areas including oncology and neurology. This is an amazing opportunity to bring your experience and knowledge to a company that effectively contributes to medicine.

Job Responsibilities

  • Assists with organizational tasks for the CSS Regulatory Affairs Global Strategic Implementation Department
  • Responsible for the maintenance of regulatory databases, trackers and systems
  • Assists with preparing the necessary documents, outlines and application forms for initial clinical study regulatory submissions, amendments, and closure of study packages in compliance with country regulatory requirements
  • Coordination of training into the Learning Management System
  • Acts as Records Management Coordinator, ensuring record retention policy and procedures are implemented
  • Creates and approves ECOs pertaining to the Coordinators projects and duties
  • Fulfills products release requests in accordance with Regulatory requirements
  • Provides operational support for economic operator and supply chain initiatives for CSS, including but not limited to those for European Authorized Representative
  • Assists in the development of best practices for Regulatory Affairs processes
  • Provides solutions to a variety of problems of limited scope and complexity
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Performs other duties assigned as needed

Skills and Requirements

  • 4-6 years of work experience, preferably but not limited to regulatory affairs
  • Bachelor diploma
  • Excellent written and verbal communication skills in English
  • Creative and good computer skills: Outlook, Power Point, One Note, Excel,
  • Detail oriented, conscientious,
  • Ability to take on diverse tasks,
  • Capacity to work in and with a diverse team

To Apply

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Keri Marshall at 0207 440 0679 or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

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