Job Description

Department Details
MEDICAL AFFAIRS & NRA
Role Summary
NATIONAL REGULATORY AFFAIRS ACTIVITIES (NRA)
Key Responsibilities
Responsible for filing following applications and receipt of approvals such as Manufacturing in (Form 25 and 28), Additional product (Form 25), Specific Quantity Export, P.O, Additional product (Form 25), Dual use NOC's for import and export NOC's ,Technical Staff, Form CT applications, Loan license, GMP Certificate, Certificate of pharmaceutical product (CoPP), Free Sale Certificate (FSC) WHO GMP Certificate and EU- Written Confirmation and other different regulatory bodies i.e. DCA and CDSCO within defined timelines and in accordance within established standards of Drugs & Cosmetic Act for API. Planning as per product requisition form, Collection of requisite documents from all concerned departments, Execution, and Follow-ups with DCA and CDSCO for following applications. Interacting with NRA, IRA & Project management team for new products in pipeline.
Educational Qualifications
Required Education Qualification: B.Sc
Required Experience: 1 - 6 years

Skills Required