Required Drug Regulatory Affairs - Pharma Formulation

Exemed

1 - 4 years

2 - 3 Lacs

Vadodara

Posted:6 hours ago| Platform:

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Skills Required

Regulatory Affairs Sugam CDSCO SEC Drug PIL FDC CT 21

Work Mode

Work from Office

Job Type

Full Time

Job Description

Company Name: Exemed Pharmaceuticals

Designation - Drug Regulatory Affairs -Officer/Sr Officer

Location - Vadodara ( Corporate Office)

Market: Domestic

Having knowledge of SUGAM portal and CDSCO website
Submission for Mfg. & Mkt. Applications [CT21/CT-18] for IND, New Drug, Subsequent New Drug, FDC.
Application of CT-05 / CT- 04
Application of CT-10 / 12/ 13
Application of import Licenses [CT-16/ Form 12/Form 08]
Knowledge of IPC submissions
Form 29 application
Preparation of presentation for Subject Expert committee (SEC)
Product Lifecycle & Management

Additionally, should be well verse with

Preparation of Module 4 & 5 Nonclinical & Clinical data
Preparation of Pack Insert (PI), Patient information leaflet (PIL) and Summary Product Characteristics (SPC)
Literature Search (Nonclinical, Clinical, Formulation etc.)
Preparation of Product Monograph
Preparation of different types of rationales (for FDC, efficacy, dosing etc.)
Aware of BABE Guidelines/ CT Phase III guidelines & Animal Toxicology

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