Regulatory Affairs Manager

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Lund, Skåne Län - Sweden
Senior Specialist / Project Manager
Pharmaceutical Research Industry

Description

The 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

Responsibilities:

  • Provide regulatory services to support international multinational clinical trials according to requests from clients:
    Preparation, review and compilation of regulatory submissions
    Liaison with authorities
    Advice/answers to regulatory questions/issues
  • Maintenance of electronic files and trackers as required
  • Submit and support clinical trial applications to regulatory authorities in the EU
  • Developing regulatory documents for clinical trial submissions and scientific advice meetings
  • 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 regulatory strategy and guidance to sponsors and other TFS departments to ensure compliance with regulations and guidance
  • Involved in continuous improvement projects with other relevant departments
  • Actively contribute to the organization and development of procedures to enhance the work at TFS
  • Participate and contribute in preparation of department SOPs, tools and Regulatory Intelligence
  • Maintain a high level of competence regarding international regulatory requirements and regulatory procedures
  • Being well-informed and updated on laws, directives and guidelines concerning regulatory affairs
  • Education and supervision of new REG personnel

Requirements

  • Fluency in both English and Swedish
  • 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; EXCEL, MS Project; and other software tools as needed

Benefits

A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients.

Job Summary

  • ID: F6013E9539
  • Department: Regulatory Affairs
  • Type: full time