Job Description
• Review documents as CTD, PMFs, to fulfill MOH requirement for registration • Familiar with TTAC portal of MOH and material registration. • Review product printing materials, labeling, specification sheets with applicable regulations and policies. • Follow-ups with the Iranian Ministry of Health on files review and ensures timely submission of additional documentation requested • Supervision of quality processes • Familiar and provision of SOPs • Gathering Pharmacovigilance and ADR reports • Develop professional relationships with MOH staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations
Requirements
• Education: Pharm. D., Bachelor’s degree in biology, Analytical or Organic chemistry or equivalent work experience of Applied, • Min 2 years’ experience in regulatory • Fluency in writing, reading and speaking of English language • Strong communication skills • Good command of computer knowledge (MS. Office) • Experience within Regulatory Affairs and/or Quality Assurance is a requirement while the candidate should be familiar with Product Registration and MOH Regulations • High team work value
Employment Type
- Full Time
Job Category
Seniority
Details
Employment type
- Full Time
Job Category
Educations
Seniority
