Regulatory Expert

Hoger Daroo Danesh Tehran

Posted Over a month ago

Job Description

  • Update local regulations and health authority requirements.
  • Coordinate with foreign and domestic companies to obtain the necessary documents.
  • Provide SOPs and implement pharmacovigilance based on PV guidelines.
  • Review the contents of CTDs and prepare them for the review of the Ministry of Health.
  • Product registration, license renewal, and submission of changes.
  • Follow up on all assigned activities in the company and the Ministry of Health correctly and regularly.

Requirements

  • Bachelor's or Master's degree.
  • At least 3 years of experience in the same position.
  • Excellent communication and presentation skills.
  • Outgoing and persuasive manner and negotiation skills.
  • Confidence and perseverance.
  • Patience and spontaneity.
  • Analytical and planning skills.
  • Flexible approach to work in order to adapt to changes.
  • Strong teamwork and networking skills.
  • Good knowledge of English.
  • Proficient in preparing and presenting documents required by the Food and Drug Organization.
  • Familiar with the organization's regulatory affairs, including obtaining and renewing drug and supplement licenses, obtaining and renewing IRC, and source registration.
  • Mastery of the TTAC system.
  • Experience in writing SOPs and guidelines.
  • Familiar with contract manufacturing.
  • Teamwork experience.
  • Appropriate public relations to refer to relevant organizations.

Employment Type

  • Full Time

Details

Employment type

  • Full Time

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