General Manager - Regulatory Affairs (Licensing & Artwork) (PSS06785)

General Manager - Regulatory Affairs (Licensing & Artwork) (PSS06785) About the client:

Key Responsibilities:

A) Head Licensing and Artwork Team:

Leading team of Artwork and Domestic licensing and new drug approvals.

B) Liaising with State FDA and CDSCO (Zonal and Central) and defining regulatory strategy and applications for drug & cosmetics licenses and certificates:

• Filing and obtaining drug and cosmetic licenses in a timely manner.
• Filing and obtaining all types of certification in a timely manner.
• Maintain regulatory approval of GMP/WHO GMP of manufacturing sites.
• Handling complaints/NSQ-related issues with the State FDA and CDSCO.

C) Liaising with FSSAI (Zonal and Central) and defining regulatory strategy and applications for licenses and compliance:

• Filing and obtaining food licenses in a timely manner..
• Compliance with FSSAI and metrology regulation for formulation, label, and advertisements.

D) Compliance and approval of domestic and international artwork:

Timely and accurate preparation and approval of artwork