Required Drug Regulatory Affairs

7 days ago


Vadodara, Gujarat, India Exemed Full time ₹ 6,00,000 - ₹ 12,00,000 per year

Company Name: Exemed Pharmaceuticals

Designation - Drug Regulatory Affairs -Officer/Sr Officer

Location - Vadodara ( Corporate Office)

Market: Domestic

Primary Job Descriptions

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

Additionally, should be well verse with

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


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