Job Objective
Regulatory Affairs Specialist is responsible for assisting in obtaining and maintaining National Health Authorities (EDA) and International approvals (as required) for Plasma supply chain facilities, products Manufacturing Facility, Plasma Exportation and finished product importation and release.
Key responsibility
- Prepare and submit all documentation related to the application of plasma supply chain facilities and plasma derived medicinal products manufacturing facility to National and International Health Authorities.
- Prepare and submit Site Master File of Plasma DC establishments, Plasma Logistic Center, Plasma Testing Laboratory, and Manufacturing Facility to Health Authorities.
- Prepare and submit of the required documents for exportation, importation, and release processes for plasma and related final product.
- Prepare the required data to generate and update the Plasma Master File.
- Maintain efficient regulatory affairs documentation archive.
- To assist Regulatory Affairs Manager in any assigned duties.
Academic Experience Required
- Bachelor s Degree in Health-related Sciences, preferably pharmaceutical area.
- Post-Graduate Certification in Quality Management.
- Knowledge of cGMP requirements preferred.
Professional Experience Required
- Typically requires a minimum of 2 years of related experience in Regulatory Affairs field.
- Preferred Pharma background.
Computing Skills
MS Office knowledge.
Personal Skills
- Organized and able to manage time effectively.
- Ability to work within a highly regulated, labor intensive environment.
- Ability to understand, explain, follow, and enforce SOPs and protocols
- Ability to plan, communicate and execute activities for the improvement of overall operations.
- Strong integrity and commitment to quality and compliance.
Languages
Written and spoken English and Arabic.
