Regulatory Affairs Manager

Rasta Imen Daroo Tehran

Posted 3 months ago

Job Description

Supervising regulatory team - To act as the Responsible Pharmacist according to MOH guidelines - To implement and manage MOH regulations in the company - Overall responsibility for compiling regulatory submissions to the MOH, Product registration, Consumer Information, literature searches and other regulatory activities. - Prepare the related documents for registration of new pharmaceutical products - To monitor and control all necessary manufacturing, packaging, associated documents, test and release of the produced batch of the pharmaceutical product. - Carrying out all the procedures for obtaining the manufacturing license of new drugs and taking timely action to renew the manufacturing license of current products according to GMP regulations. - Receiving reports of periodic inspections of the MOH in order to correct and eliminate deficiencies and follow up to eliminate deficiencies and report corrective actions - Planning for continuous modification and improvement and carrying out internal inspection - Submissions to the MOH, product registration, consumer information and all regulatory activities

Requirements

- Education: Pharmacist (Pharm D) - Experience: at least 3 years’ experience as regulatory manager - Highly effective communication, presentation and creativeness - Capability to work in a team - Self-motivation and well organized - Excellent communication and negotiation skills - Fluent in English - Good command of computer knowledge

Job Categories

  • Quality Control, QA & Inspection
  • Healthcare - Pharmaceutical

Employment type

  • Full Time

Education

  • Pharmacy/Pharmacology

Seniority

  • Manager

Job Categories

  • Quality Control, QA & Inspection
  • Healthcare - Pharmaceutical

Employment type:

  • Full Time

Education:

  • Pharmacy/Pharmacology

Seniority:

  • Manager

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