- Follow-ups with the Iranian Ministry of Health on files review and ensures timely submission of additional documentation requested in field of pharmaceutical, supplement and cosmeceutical products
- Support all Regulatory Affairs activities in order to achieve and maintain registrations in compliance with all national and regional Regulatory and legal obligations
- Supervision of medical devices procedures
- Familiar with 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
- Review documents as CTD, PMFs, to fulfill MOH requirement for registration
- Familiar with TTAC portal of MOH
- Review product printing materials, labeling, specification sheets with applicable regulations and policies
Requirements
Skills and Qualifications
- Age: Maximum 35 years old
- Education: Pharm.D.
- Professional experience: Minimum 3 years in the field of Pharma (experience in multinational companies is a plus)
- Skills
Good communication and interpersonal skills
Perfect command of English language (verbal, written and translation)
Good MS Office proficiency (especially Excel and Word)
Familiar with TTAC system
Being a qualified pharmacovigilance professional is preferred
Being a qualified person for medical devices is preferred
- Traits: Hardworking, multitasking capability, team working, self-motivated, flexible, positive and active attitude, willing to take responsibility, enthusiastic about learning