Regulatory Affairs Specialist (Product Importation)

Regulatory Affairs Specialist (Product Importation)

Job Description

-Following and being updated for the local regulations and health authorities’ requirements -Updating the company and related departments with the latest regulations of MOH (Ministry of Health) -Updating regulatory data sheets and report it on regular bases. -Coordination with foreign companies and local manufacturing site to obtain necessary documents -Providing SOPs and implementing pharmacovigilance base on PV guidelines -Reviewing the CTDs contents and preparing it for MOH review -Preparing the forms and documents to be sent to MOH -Product registration, license renewal and variation submission -Visiting MOH persons regularly to follow up pending tasks with them -Following all the companies' activities in MOH properly and regularly -Translating the needed documents to be submitted to MOH -Preparing the bilingual (English-Persian) patient leaflet and packing materials

Requirements

-Pharmacist (Pharm D) -Preferably 2 years’ experience in the field of regulatory affairs of pharmaceutical products -Good understanding of the relevant Iranian MOH and Quality framework -Familiar with IDL and Brand Registration -Familiar with Dossier and CTD -Familiar with the procedure of TTAC -Familiar with pharmacovigilance guidelines -Having a good knowledge in English, written and spoken -Having Computer literacy, Proficient in word and excel and Outlook -Excellent in interpersonal relations, Flexibility and adaptability, self -motivation, loyalty and well-recognizing -Strong analytical skills, data oriented, hardworking, team worker -Familiar with importation, contract and under license manufacturing process and regulations

This position is no longer available.

About Company

100-499 employees

Koushan Pharmed (KP) is an Iranian privately-owned specialty pharmaceutical company focused on the import, development, manufacturing, sales and marketing of generic pharmaceuticals, OTCs and medical devices. The KP partners with reputable pharmaceutical companies in the field of Respiratory, Gynecology, Cardiovascular, Supplements, etc.

Similar Jobs

Cobel Darou | استخدام در شرکت کوبل دارو

a month ago

Pouyan Sanat Nahad (PSN) | استخدام در پويان صنعت نهاد (پي.اس.ان)

Laboratory Expert

Full Time

Pouyan Sanat Nahad (PSN)

Tehran

20 days ago

Rougine Pharmed | استخدام در روژين فارمد

22 days ago

Vana Darou Gostar | استخدام در وانا دارو گستر

a month ago

Afa (Aftab Forouzan Aria) | استخدام در آفا (آفتاب فروزان آریا)

Sales Expert

Full Time

Afa (Aftab Forouzan Aria)

Tehran

2 months ago

 Bayer Parsian AG | استخدام در باير پارسيان آگ

Medical Representative

Full Time

Bayer Parsian AG

Tehran

2 months ago

Avan Darman Novin | استخدام در آوان درمان نوين

Medical Representative

Full Time

Avan Darman Novin

Tehran

15 days ago

Orchid Pharmed | استخدام در اُرکيد فارمد

a month ago

Novo Nordisk Pars | استخدام در نوو نور دیسک پارس

2 months ago

Roche Pars | استخدام در روشه پارس

13 days ago