About the client: PSS has been mandated to hire a General Manager - Regulatory Affairs (Licensing & Artwork) for a leading MNC organization in the healthcare space.

Job Purpose: Responsible for the state Regulatory affairs.

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

Qualifications & Experience:

  • B.Pharm/ B.Sc./ M.Pharma/ Msc.
  • 15- 18 years experience.

  Job Summary

Posted On:

25-Oct-2024

Function:

Legal & Regulatory

Industry:

Pharmaceuticals & Lifesciences

Location:

Mumbai

Employment Type:

Full Time