Product Release Specialist is responsible for the of Finished Product Importation and Exportation submissions to Health Regulatory Agencies to ensure the final release, as well of support for pharmacovigilance tasks related of the Finished Product in the market.
Key responsibility
- Revision and submission of Finished Product documentation required for Finished Product Importation / Exportation, ensuring final release of the product.
- Coordinate delivery of samples to National Health Authorities (EDA) required for Finished Product release.
- Ensuring compliance with current Finished Product Importation / Exportation and release regulations and guidelines.
- Maintain efficient Regulatory Affairs documentation archive.
- To assist Regulatory Affairs Manager in any assigned duties.
Academic experience required
- Bachelors Degree in Health-related Sciences, preferably pharmaceutical area.
- Knowledge of cGMP requirements; Good storage and Distribution practice.
Professional experience required
- Minimum of 2 years of related Reg Affairs Product Importation / Exportation experience in a pharmaceutical, GMP environment is required.
- Comprehensive knowledge and understanding of cGMPs, EMA regulations.
Computing skills
MS Office knowledge.
Specific experience with SAP is preferred.
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
Excellent verbal and written communication skills in the English and Arabic language
