Regulatory Affairs Expert

Tadbir Kalaye Jam (TKJ)

Tehran

Posted 3 days ago

Job Description

• Assist in develop of new products. The applicant must have a spirit of hard work and patience to achieve the goals, she/ he also needs to be motivated to solve a technical challenge • Create and manage effective communication and close collaboration with MOH • Keeping up-to-date with the latest news in MOH, syndicates and pharmaceutical industry. • Preparing and completing Regulatory documentation, provide reports on a regular basis to QA manager. • Establish and maintain a system for tracking changes in documents submitted to regulatory authorities or partners. • Support in collecting and coordinate information and prepare regulatory documentation for submission to regulatory affairs. • Support maintenance of regulatory files in compliance with regulations and standards applicable to company products. • Capable of traveling and site visits • 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 Activity Team working in preparing the required documentation for submitting the pharmaceutical dossier into the ministry of health includes CTDs, SOPs, Reports, and ….

Requirements

• Junior professional (Master’s degree in health professions or chemistry) • At least 2 years of experience in the regulatory field and pharmaceutical company • Familiar with regulatory affairs and MOH procedures • Strong communication skills • High team work value • English proficiency is plus • Familiar with TTAC website, registration of supplements and APIs, medicines & getting IRC in MOH. Support the commanded strategies to increase the time and accuracy of regulatory compliance. • Familiar with all the production steps in Iran , familiar with product analysis, stability studies and able to follow up the case with the labs and local manufacturers.

Job Categories

  • Healthcare - Pharmaceutical
  • Quality Control, QA & Inspection

Employment type

  • Full Time

Seniority

  • Junior Professional

Job Categories

  • Healthcare - Pharmaceutical
  • Quality Control, QA & Inspection

Employment type:

  • Full Time

Seniority:

  • Junior Professional

To see more jobs that fit your career

Similar Jobs

Herbal Pharmacist

Herrmman International Group

Tehran
3 days ago

Medical Representative

Arena Life Science

Mashhad
1 month ago
Qazvin
1 month ago
Yazd
5 hours ago

QC Intern

Savola Behshahr Company (SBC)

Tehran
24 days ago
Tehran
28 days ago
Tehran
1 month ago

Quality Assurance Specialist

Zar Industrial Group

Hashtgerd
24 days ago
Tehran
1 month ago

Commercial Expert

Arena Life Science

Tehran
1 month ago

Salary Estimator

Discover your current worth in the job market.