AGM Regulatory Affairs - DGCI

10 - 18 years

10 - 14 Lacs

Dholka

Posted:6 days ago| Platform: Naukri logo

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Regulatory Affairs DGCI FDA Regulatory Compliance

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities Liaison with Food & Drugs Control Administration, Gandhinagar/circle offices/CDSCO for various applications including but not limited to Product Permissions for manufacturing COPPs Various certificates for tender (FSC, Performance certificate, Non-conviction certificate) Inspections for WHO GMP/Schedule M GMP certification Technical persons approval Technical person application verification. Liaison with CDSCO, West Zone, Form 29 Export licenses Loan license Manufacturing licence renewal for all plants Wholesale licences Submission of commercial batches to CDL Kasauli for testing Submission of quarterly returns to NCB/CBN Handling NSQs Experience in submissions through Sugam, NSWS and ONDLS portals

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Cadila Pharmaceuticals
Cadila Pharmaceuticals

Pharmaceuticals

Ahmedabad

7000+ Employees

51 Jobs

    Key People

  • Pankaj R. Patel

    Chairman & Managing Director
  • Siddharth N. Patel

    Vice Chairman & Managing Director

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