امیددارو سلامت
امیددارو سلامت

International Regulatory Affairs Manager

Tehran/ Janat Abad
Suitable For Disabled
Full Time
Saturday to Wednesday 8:00 to 5:00
-
Health insurance -Lunch
51 - 200 employees
Pharmaceutical
Iranian company dealing only with Iranian entities
1382
Privately held
توضیحات بیشتر

key Requirements

3 years experience in similar position
Experience in Pharmaceutical industry
PhD Pharmacy/Pharmacology or Chemistry

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:
Ph.D. degree in Pharmacy.
Minimum 3 years of experience in regulatory affairs, in pharmaceuticals or nutraceuticals in Iran or international market.
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
27 - 40 Years Old
Gender
Men / Women
Military service
Military service must be done
Education
PhD| Pharmacy/Pharmacology PhD| Chemistry
Language
English| Advanced 90%
Software
Microsoft Excel| Intermediate Microsoft Word| Intermediate Microsoft Outlook| Intermediate

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