● Support all regulatory affairs activities in order to achieve and maintain registration in compliance with all national and regional regulations.
● Generate and review supplements dossier.
● Review product labeling, batch records, specification sheets, or test methods for compliance with applicable regulations.
● Gather and prepare the regulatory documents for supplements products.
● Preparation of all required documents such as specifications, certificates, and reports for different departments.
● Compile registration files for new products.
● Coordinate and support manufacturing process on site.
● Collect and compile statistical quality data.
● Interpret and implement quality assurance standards.
● SOP preparation.
● Prepare or maintain technical files as necessary to obtain and sustain product approval.
● Review packaging Artwork based on the regulation of the UK and Iran.
● Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
● Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
● Follow up R&D process from the R&D department.
● Follow up finished products analysis.
● Pharm. D.
● Minimum 2 years of related work experience.
● Knowledge of supplements technical files and regulations.
● Familiarity with SOP writing.
● Highly skilled in working with MS Office software and the internet.
● Fluency in English.