Job Description

Department Details
Role Summary
National Regulatory Affairs
Key Responsibilities

• Overall responsibilities to lead NRA department functions (Site-3, Site-5 and Site-6).
• 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 licence, 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.
• Accompanied government inspectors during inspections and provide post-inspection follow-up information as requested.
• Prepare query response for the regulatory inspections.
• Maintain the relation with Regulatory Authority/ officers and other Government departments by doing frequently meetings at CDSCO Sub Zonal offices/SLA's (Vishakapatnam, Guntur and Hyderabad).
• Technical Discussion and Liaison with Regulatory Authorities, Government officer to secure the permission within the business timelines.
• Responsible for Maintaining of Original Regulatory Licenses Master files in soft and hard copies.
• Updating Check list based on Trend analysis made on the queries received from DCA
• Completion of the works allotted by the Head of the department.

Educational Qualifications
Required Education Qualification: B.pharma
Required Experience: 5 - 10 years