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.
Posted On:
25-Oct-2024
Function:
Legal & Regulatory
Industry:
Pharmaceuticals & Lifesciences
Location:
Mumbai
Employment Type:
Full Time