Key Accountabilities :

Managing local regulatory and global compliance and business continuity of existing and new products of EPD India +ex India (Srilanka , Nepal, Bhutan, Maldives +++)

Responsible for Global compliance requirements of all EPD India products

• Darius
• CCDS
• Prescription Information (PI)

Responsible for Global compliance requirements of all EPD India products with Indian and ex India regulations

• Aligned with DCGI /FSSAI /Ayush /NMRA /DDA/Maldives regulations
•  Pharmacopeial requirements

Responsible for labelling compliance /revisions of all FSSAI products

• FSSAI – Revising formulations/labelling  as per changed regulations /guidelines
• Promotional Inputs review
• Prescription information
• Change control management

Responsible for Risk analysis and mitigation

Maintaining database of Updated product information

Risk identification

Projects on Risk Mitigation

Regularization of product with DCGI/FSSAI /IP requirements

Responsible for labelling compliance  in other businesses

Consumer Care

International business

Vaccines

Medical Devices

Responsible for all audits including global audits of RA process and RA compliance

Qualification :

Education M.Pharm / Degree in RA

Experience 10-12 years in overall RA compliance and labelling management both India and  EX India in DCGI and Vaccines