
Required Drug Regulatory Affairs
2 days ago
Company Name: Exemed Pharmaceuticals
Designation - Drug Regulatory Affairs -Officer/Sr Officer
Location - Vadodara ( Corporate Office)
Market: Domestic
Primary Job Descriptions
- 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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