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Regulatory Affairs Manager, home or office based

  • TFS
  • Full time
  • Denmark
  • 10/02/2021

TFS is a Global CRO headquartered in Sweden. We genuinely believe that “Global in mind and local at heart” is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory requirements in every country where we operate. At TFS, you will be offered the possibility to develop in a global organization with a company culture distinguished by passion, innovation and talent.

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 in English and Swedish languages
  • Demonstrate proficiency using typical word processing; spreadsheets desirable; and presentation software a plus

Benefits

  • Health Insurance
  • Occupational Work Injury Insurance
  • Corporate pension plan
  • Global General Liability Insurance
  • Global Travel Insurance
  • Flexible working schedule

About TFS

We believe that a company with ethical and transparent values has a better chance of attracting skilled employees and building long-term relationships.

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