Senior Regulatory Affairs Manager

Scope of the job

The Senior Regulatory Affairs Manager works under the hierarchical supervision of the Head of Regulatory Affairs Department.

As a Senior Regulatory Affairs Manager (Sr RAM) you play a role in the management of the Regulatory Affairs Department for workload planning and staff coaching throughout the whole life cycle of the clinical trial applications across Europe.

Main responsibilities / Major Activities

  • First entry port of any new project that requires regulatory advice during the planning phase.
  • Provide ongoing updates on changes in the regulatory environment
  • Advise on and review regulatory documents to ensure compliance with applicable regulations and propose actions, if required
  • Ensure together with the Head of Dept. initial and continuous training as well as personal development & regulatory advice to all members of the RAU
  • Support the Head of Department in the development of procedures and templates
  • Back up of the Head of Dept. at relevant meetings (General team meetings, meetings with industry etc.)

Profile

  • Master degree in life Sciences
  • 8 years of relevant experience in international clinical trial regulatory environment from a sponsor perspective in a management/decision making position
  • Good knowledge of current and future EU regulatory environment and related impacts on the work organization.
  • Can demonstrate the ability to coordinate work transversally with other units, reach deliverables by deadlines
  • Can demonstrate expertise in QC of regulatory submission documents
  • Excellent proven team management experience, familiar with project management tools for planning
  • Good organization skills, ability of multi-task
  • Excellent written and verbal English skills.

Application form


*Compulsary fields
Application should be sent in English

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