الوصف الوظيفي
Regulatory Affairs Specialist is responsible for overseeing and managing all regulatory tasks related todrug registration, compliance, and submission in Lebanon. This role involves ensuring adherence toLebanese Ministry of Health (MoH) regulations, maintaining up-to-date knowledge of regulatory requirements, and supporting clinical operations and product registration processes. The specialist willalso collaborate with various stakeholders, both internally and externally, to ensure the timelysubmission and approval of regulatory documents and product registrations.Main Responsibilities:1- Actively contribute to the development and implementation of regulatory strategies.2- Provide regulatory support for operations, including reviewing essential documents, study scientific and legal documents, and ensuring compliance with MoH regulations.3- Ensure all documents comply with Lebanese regulations and MoH requirements.4- Stay up to date with changes in Lebanese drug regulatory legislation and guidelines, ensuring the organization remains compliant.5- Review and ensure the completeness and accuracy of regulatory files submission to the MoH.6- Follow up on all pending technical files at the MoH and provide updates as necessary.7- Provide periodic updates to management on the status of product registrations and other regulatory activities.8- Monitor progress towards fulfilling regulatory drug submissions’ forecasts, ensuring quality standards are met and deadlines are adhered to.9- Manage the registration process for all products with the National Social Security Fund (NSSF).10- Review and verify all imported invoices to ensure compliance with MoH rules and regulations.
