Regulatory Affairs Manager

Regulatory Affairs Manager

TFS

London, United Kingdom

Description

Regulatory Affairs Manager is part of the Project Delivery organization and will work operationally on preparing, conducting and completing Regulatory Affairs tasks in assigned Study Teams, according to company policies, SOPs and regulatory requirements.

Essential job functions:

  • Provide regulatory services according to requests from clients:
  • Maintenance of electronic files
  • Participate in preparation of department SOPs and tools
  • Maintain a high level of competence regarding international regulatory requirements and regulatory procedures
    • Preparation, review and compilation of regulatory submissions
    • Liaison with authorities
    • Advice/answers to regulatory questions/issues
  • Responsible for the updates of regulatory trackers and templates
  • May act as a Project Lead for REG-only projects
  • Participate in relevant meetings. Forward information to relevant members of the department or study team members
  • Provide internal support to other relevant departments
  • Involved in improvement projects with other relevant departments
  • Actively contribute to the organization and development of routines to enhance the work at TFS
  • Being well-informed and updated on laws, directives and guidelines concerning regulatory affairs
  • Education and supervision of new REG personnel
  • Participate in marketing activities

Requirements

  • Bachelor’s Degree, preferably in life science or pharmacy; or equivalent
  • 5 years of relevant experience
  • Able to work in a fast-paced environment with changing priorities
  • Understand the basic terminology and science associated with the assigned drugs
  • Understanding of the Good Clinical Practice regulations, ICH guidelines, Clinical Trial Regulation and internal SOPs
  • Ability to work independently as well as in a team matrix organization with little or no supervision
  • Excellent written and verbal communication skills
  • Demonstrate proficiency using typical word processing; spreadsheets desirable; and presentation software a plus

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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