Objective: Regulatory Affairs expert
Job Type:Full Time
Skills & Experience
- University degree chemistry and related subjects
At least 3 years of experience in pharmaceutical Company.
- Core Competencies:
– Capable to work in a team
– Independent, motivated and initiative
– Strong communication and negotiation skills
– Hard working and Integrated
– Task oriented
– Result oriented
– Age: 25-40
-Language Skills: Fluent in English
-Computer Skills: MS Office programs
-Current Residence: Tehran
-Travel Requirements: Within the Country & other Countries
- Supervision of all activities related to the quality of products according to the national and international standards including GMP, GLP, GSP, GDP and etc.
- Conducting the preparation of all required documents such as guidelines, SOPs, specifications, certificates and reports for different departments.
- Conducting the process of registration of products and preparing CTDs and other requirements.
- Batch Control and release, to check and monitor all aspects of GMP and related issues,
- Gathering and preparing the documents for Iran’s Drug List, Brand Registration, Renewal and Variation
- Submitting the required documents for registration to Iran’s MOH
- Monitoring and following the registration process both with Iran’s MOH and related Foreign Companies
- Maintaining familiarity with imported and to be imported foreign company products
- Writing comprehensible, user-friendly, clear Persian product information leaflets and labels