Regulatory Affairs Specialist

il y a 3 semaines


Paris, Île-de-France ProductLife Group Temps plein

Regulatory Affairs Specialist

We are seeking a Regulatory Affairs Specialist to join our team at ProductLife Group. As a key member of our regulatory team, you will be responsible for ensuring the delivery of regulatory activities performed onsite in the Paris region.

About us:

Group 10 Responsibilities:

  • Coordination of the collection of information relating to regulatory requirements or the analysis of the regulatory impact of changes control
  • Follow-up of the subcontractor in charge of the constitution of variation files according to the legislation and local requirements,
  • Monitoring of the submission of variations / their approval by the local health authorities, in accordance with the established schedule,
  • Monitoring and / or updating of packaging (modification and validation of packaging items)
  • Update, extraction and validation of information from regulatory databases,
  • Establishment and writing of summaries on the progress of the projects
  • Update of dashboards and electronic archiving

Group 11 Education:

  • Pharmacist degree is COMPULSORY
  • Degree in Regulatory Affairs is a plus

Group 12 Experience:

  • Minimum of 5 years 'experience, in regulatory affairs for pharmaceutical products

Group 13 Skills:

  • Knowledge and experience with French regulations
  • Knowledge of European Regulations is a plus
  • Master of English and French languages for business continuity
  • Ability to work in a fast-paced environment
  • Entrepreneurial mindset
  • Change facilitator
  • Good stress management

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