امیددارو سلامت
امیددارو سلامت

Regulatory Affairs Manager

Tehran/ Janat Abad
Full Time
Saturday to Wednesday 8 to 17
-
Health insurance -Lunch
51 - 200 employees
Pharmaceutical
Iranian company dealing only with Iranian entities
1382
Privately held
توضیحات بیشتر

key Requirements

5 years experience in similar position
Experience in Pharmaceutical industry
Managerial work experience
Master Chemistry or Pharmacy/Pharmacology
language English-Advanced

Job Description

Key Responsibilities:

  • Prepare, compile, and submit dossiers for product registration (local and international).
  • Review and maintain regulatory documentation for APIs, excipients, and nutraceutical ingredients.
  • Stay updated with regulatory changes in target markets.
  • Liaise with suppliers to obtain technical and regulatory documentation (DMFs, COAs, GMP certificates, etc.).
  • Ensure product claims and labeling comply with national and international regulations.
  • Collaborate with sales and sourcing teams to assess regulatory risks in new product selections.
  • Respond to regulatory queries from authorities or clients in a timely manner.
  • Support internal audits and ensure regulatory documentation is audit-ready.

Qualifications & Requirements:

  • Master's or Ph.D. degree in Pharmacy or Chemistry.
  • Minimum 5 years of experience in regulatory affairs, in pharmaceuticals or nutraceuticals.
  • Strong knowledge of regulatory requirements (Iran FDA and International guidelines).
  • Experience with product registration, dossier compilation, and regulatory submissions.
  • Proficient in reviewing technical documents and certificates.
  • Strong organizational and communication skills.
  • Fluent in English (written and spoken).

Job Requirements

Age
28 - 40 Years Old
Gender
Men / Women
Military service
Military service must be done
Education
Master| Chemistry Master| Pharmacy/Pharmacology
Language
English| Advanced 90%
Software
Microsoft Word| Intermediate Microsoft Excel| Intermediate Microsoft Outlook| Intermediate

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