About the job

To maintain ongoing exciting projects, we are urgently looking for a Regulatory Affairs Specialist to join our teams in France.

About us

Group 10
Responsibilities

  • Drive the preparation of EU and National Marketing Authorisation Applications
  • Preparation and submission of documentation for post-approval applications including, but not limited to, Type IA, Type IB, Type II and MAH Transfers/Change of Ownership
  • Preparation and submission of Technical/Site Transfer Applications
  • Providing support during external and unannounced audits.
  • Responding to internal requests for technical and/or regulatory information.
  • Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
  • Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.
  • Ensuring compliance with the regulations of the ANSM and EMA
  • Use a variety of software packages (Microsoft Office Suite, Veeva or comparable EDMS, LorenZ, Trackwise etc) to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data
  • General regulatory administration duties and compliance requirements
  • Management of artwork generation
  • Able to coach and mentor junior colleagues in a technical sense (no LM responsibility)

Group 11
Education

  • Pharmacy Degree

Group 12
Experience

  • At least 8 years of experience in RA in a Pharmaceutical Company or Service Provider
  • FR and EU lifecycle maintenance experience

Group 13
Skills

  • French Native Speaker
  • Knowledge of FR and EU regulatory regulations
  • A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget
  • Good organizational skills
  • Good communication skills
  • Pro-active attitude and able to work on own initiative as well as part of a team
  • Ability to prioritize different workloads/multi-task
  • Personal responsibility for ensuring a high standard of work
  • Good IT skills/knowledge
  • Experience of promotional/non-promotional activities would be an advantage

Regulatory Affairs Specialist - 713