Regulatory Affairs Specialist

il y a 4 semaines


Paris, Île-de-France ProductLife Group Temps plein

Regulatory Affairs Specialist

We are seeking a Regulatory Affairs Specialist to ensure the delivery of regulatory activities performed onsite in Paris region.

About us

ProductLife Group

Responsibilities

Under the responsibility of the regulatory coordinator of this project and in close collaboration with subsidiaries, production sites, CMC Regulatory Project Managers, subcontracting platforms involved in this project, supply teams, project managers in charge countries, activities will cover:

  • 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

Education

Pharmacist degree is COMPULSORY

Degree in Regulatory Affairs is a plus

Experience

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

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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