Regulatory Affairs Specialist
il y a 21 heures
Regulatory Affairs Specialist
We are seeking a Regulatory Affairs Specialist to ensure the delivery of regulatory activities performed onsite in Paris region as part of a project for one of our Top Clients.
About us
ProductLife Group
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
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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