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

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.
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Compliance with FSSAI and metrology regulations for formulation, labeling, and advertisements.
D) Compliance and approval of domestic and international artwork: Timely and accurate preparation and approval of artwork.
Qualifications & Experience: Pharm/ B.
1518 years experience.
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