Regulatory Expert

Omid Darou Salamat

Tehran

Posted 6 months ago

Job Description

● 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.

Requirements

● 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.

Employment Type

  • Full Time

Employment type

  • Full Time

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