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Regulatory Affairs Specialist
il y a 1 mois
Regulatory Affairs Specialist
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at ProductLife Group. As a key member of our project team, you will be responsible for ensuring the delivery of regulatory activities performed onsite in the Paris region.
About us
ProductLife Group is a leading company in the pharmaceutical industry, and we are committed to excellence in all aspects of our business. Our team is dedicated to providing high-quality services to our clients, and we are looking for a talented Regulatory Affairs Specialist to join our team.
Responsibilities
As a Regulatory Affairs Specialist, you will be responsible for the following tasks:
- 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
Requirements
To be successful in this role, you will need to have the following qualifications and experience:
- Pharmacist degree is compulsory
- Master of English and French languages for business continuity
- Minimum of 5 years' experience in regulatory affairs for pharmaceutical products
- Knowledge and experience with French regulations
- Knowledge of European Regulations is a plus
Skills
We are looking for a candidate with the following skills:
- Ability to work in a fast-paced environment
- Entrepreneurial mindset
- Change facilitator
- Good stress management
Language
The working language is English, and you will need to have a good command of the language to be successful in this role.
