● Do regulatory affairs.
● Comply registration file of drugs (CTD) and supplements (PMF) regarding to new pharmaceutical production.
● Batch release and monitoring of documentation.
● Supervise quality assurance matters.
● Compilation, control and review of documents.
Requirements
● Doctor of Pharmacy.
● More than 3 years of pharmaceutical industry experience.
● Fluent in TTAC registration techniques and CTD and PMF documentation.
● Fluent in quality assurance.
● Fluent in pharmaceutical processes and manufacturing.
● Fluent in GMP and FDA regulations and ISO requirements.
● Excellent verbal and written communication skills.
● Reliable, responsible, dependable and ability to work in a team.