Descripción
For our client, we are looking for a Regulatory Affairs Specialist : Main responsabilities:
- Be responsible for the registration, writing, coordination, implementation, execution, control and completion of product registrations
- Provide regulatory support for registrations, maintenance and post-marketing activities
- Prepare submissions for new product approvals
- Prepare and maintain all required documentation for assigned products/projects
- Create/review relevant documents, including change controls, manufacturing changes, instruction for use and product development reports
- Manage the packaging materials workflow from the artwork to ready to print, review and approve the packaging materials by delegation
- Communicate with customers and health authorities to respond to regulatory concerns/questions
- Provide regulatory intelligence and follow international legislation and guidelines to evaluate their impact on existing registration files
Your profile:
- Degree in Life Sciences (pharmaceutical, medical, healthcare)
- Minimum 8 years of experience in regulatory affairs within the pharmaceutical and/or medical device industry
- French and English (C1 level)
- Medical device and drug experience essential, including relevant experience in new product development and strategic understanding of registration processes
- Good knowledge of ECTD