- Life Sciences
- Pharma y Biotech - Medico
- sector empresa
- Química Farma
- tipo de contrato
- técnico registros
- our client
Important and prestigious company in the pharmaceutical sector is looking for a Regulatory Affairs Technician.
- your functions
- Writing and reviewing of regulatory variation record cards, variation dossiers, complete parts ofModule 3 or other additional documentation related to products manufactured.
- Review of technical documentation.
- Regulatory compliance for existing dossiers.
- Dossier compliance verification of analytical methods, manufacturing instructions and other
- Write and manage renewals for site drug products and for site registration
- Organization/assistance to meetings with the suitable people involved in the writing of a regulatory dossier.
- Manage of documentation related to quality assurance.
- position requisites
- Degree in Pharmacy or Chemistry.
- English (good level is a must) and French (recommended).
- Knowledge in drug product, manufacturing process and
regulatory dossier of solid pharmaceutical forms.
- Practical experiences on computers.
- Knowledge in pharmaceutical regulations and guidelines.
- Experience in writing regulatory variations, answers to health
authorities and CMC documentation.
- Experience in drug product transfers.
- Methodical and practical, analytical thought and synthesis
- Experiencia: 2 años