Regulatory Affairs Expert

 

The Role

Objective: Regulatory Affairs expert

 

Department:Regulatory
Project Location(s):Tehran-Karaj
Education:Pharmacy
Salary:--
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

Responsibilities

  • 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