Regulatory Affairs Specialist
il y a 10 heures
ProductLife Group is seeking a highly skilled Regulatory Affairs Specialist to join our team in Paris region. As a key member of our project team, you will be responsible for ensuring the delivery of regulatory activities performed onsite.
About the RoleUnder the guidance of the regulatory coordinator, you will work closely with subsidiaries, production sites, CMC Regulatory Project Managers, subcontracting platforms, supply teams, and project managers to coordinate regulatory activities. Your responsibilities will include:
- Collection and analysis of regulatory requirements and changes control
- Follow-up of subcontractors for variation file constitution
- Monitoring of variation submissions and approvals
- Update and validation of packaging information
- Extraction and validation of regulatory database information
- Establishment of project summaries and dashboards
To be successful in this role, you will need:
- Pharmacist degree (compulsory)
- Regulatory Affairs degree (desirable)
- Minimum 5 years' experience in regulatory affairs for pharmaceutical products
- Knowledge of French regulations (essential)
- Knowledge of European Regulations (desirable)
- Excellent English and French language skills
- Ability to work in a fast-paced environment
- Entrepreneurial mindset and change facilitation skills
As a Regulatory Affairs Specialist at ProductLife Group, you will have the opportunity to work on exciting projects, develop your skills, and contribute to the success of our team.
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