Overall responsibility for the area of Regulatory Affairs, including but not limited to the following:
Preparing documents and samples for external Regulatory Affairs departments. Communication with external stakeholders including Global Regulatory Affairs, Affiliates and Competent Authorities is an integral part of this role.
Tracking of variations and global change controls and ensuring that changes are implemented only when approved.
Relevant information must be shared with affected stake-holders .
Maintaining of Product & Shelf Life Specifications.
Ensuring compliance of all activities with GMP regulations.
With regard to Variation regulations ? be able to interpret and advise on the variation types.
Ensuring that the dossiers submitted to the various regulatory authorities reflect actual activities in the plant and are compliant.
Preparation of the annual report to FDA and the variation report & assessment for periodic quality review.
Maintenance of SOPs, Site Master File and manufacturing authorization.
Excellent communication skills are essential to this role.
The successful candidate must have proven ability to multi-task and to work under pressure, often having to respond to requests in a very short time period.
Attention to detail and strong technical skills with ability to interpret data are essential to this role.
The successful candidate must have a good understanding of both Analytical and Production processes.
Requirements:
It is imperative that the successful candidate has excellent communication skills, report writing and reviewing skills, good attention to detail, and proven initiative.
The position requires a third level qualification in a relevant scientific discipline.
Package:
Contract rate - Negotiable based on experience
Minimum Contract duration: 6 months
Job Description
Overall responsibility for the area of Regulatory Affairs, including but not limited to the following:
Preparing documents and samples for external Regulatory Affairs departments. Communication with external stakeholders including Global Regulatory Affairs, Affiliates and Competent Authorities is an integral part of this role.
Tracking of variations and global change controls and ensuring that changes are implemented only when approved.
Relevant information must be shared with affected stake-holders .
Maintaining of Product & Shelf Life Specifications.
Ensuring compliance of all activities with GMP regulations.
With regard to Variation regulations ? be able to interpret and advise on the variation types.
Ensuring that the dossiers submitted to the various regulatory authorities reflect actual activities in the plant and are compliant.
Preparation of the annual report to FDA and the variation report & assessment for periodic quality review.
Maintenance of SOPs, Site Master File and manufacturing authorization.
Excellent communication skills are essential to this role.
The successful candidate must have proven ability to multi-task and to work under pressure, often having to respond to requests in a very short time period.
Attention to detail and strong technical skills with ability to interpret data are essential to this role.
The successful candidate must have a good understanding of both Analytical and Production processes.
Requirements:
It is imperative that the successful candidate has excellent communication skills, report writing and reviewing skills, good attention to detail, and proven initiative.
The position requires a third level qualification in a relevant scientific discipline.
Package:
Contract rate - Negotiable based on experience
Minimum Contract duration: 6 months
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical