Regulatory Affairs Manager

 

The Role

Objective: Regulatory Affairs Manager

 

Department:Regulatory
Project Location(s):Tehran-Karaj
Education:Pharmacy
Salary:--
Job Type:Full Time

Skills & Experience

  • University degree in Pharmacy
    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.
  • Managing for preparation of all required documents such as guidelines, SOPs, specifications, certificates and reports for different departments.
  • Managing 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, to communicate with IRFDA and other foreign authorities as required, to accompany the auditors during GMP inspections.
  • 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
  • Keeping up-to-date with changes in regulatory legislation and guidelines
  • Obtaining marketing permission from Iran’s MOH according to the regulation
  • Acting as a link between companies and Iran’s MOH, ensuring that products are manufactured and distributed in compliance with appropriate legislation
  • Writing comprehensible, user-friendly, clear Persian product information leaflets and labels
  • Ensuring that quality standards are met and submissions meet strict deadlines