Temporary Regulatory Compliance Specialist (Fixed - 12mths)
Temporary Regulatory Compliance Specialist
(Fixed Contract - 12mths)
Main Responsibilities include but not limited to the following:
- Ensuring that the dossiers submitted to the various regulatory authorities reflect activities in the plant and are compliant.
- Ensuring compliance of all activities with GMP regulations (EU, FDA, Japan) within the Company and the Development of Regulatory Systems/Standard.
- Tracking of variations and global change controls and ensuring that changes are reflected in the dossiers. Relevant information must be shared with affected stake-holders.
Requirements for the Position:
- Excellent communication skills are essential to this role. The successful candidate must have proven ability to multi-task and to work under pressure.
- Attention to detail and strong technical skills with ability to interpret data are essential to this role.
- Strong knowledge and experience of pharmaceutical process (manufacturing & analytical).
- QA/Regulatory experience is an advantage.
- Third level degree in a relevant scientific discipline.