Experience

Psychotropics India Ltd.

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Officer

  • Mar 2016 - Present

  Compiling, reviewing and submission of Dossiers in CTD/ACTD format as per regulatory guidelines. Preparation of documents for certificate of pharmaceutical product (like Process validation Report & Protocol, Master formula Record, Product development Report & Protocol, Annual Product Quality review). Coordinate with QC, Production and R&D department for preparation of Drug Dossiers of Pharmaceutical formulations. Local FDA docs, Preparation- Product permission, COPP. Knowledge of US FDA regulations, ICH, PIC/S & WHO-GMP. Preparation of packing material specification MOA & COA. Reviewing Package Insert, Artwork. Other documentation.



Rivpra Formulation Pvt. Ltd.

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Officer

  • Mar 2014 - Feb 2016

   Compiling, reviewing and submission of Dossiers in CTD/ACTD format as per regulatory guidelines. Preparation of documents for certificate of pharmaceutical product (like Process validation Report & Protocol, Master formula Record, Product development Report & Protocol, Annual Product Quality review). Coordinate with QC, Production and R&D department for preparation of Drug Dossiers of Pharmaceutical formulations. Local FDA docs, Preparation- Product permission, COPP. Knowledge of US FDA regulations, ICH, PIC/S & WHO-GMP. Preparation of packing material specification MOA & COA. Reviewing Package Insert, Artwork. Other documentation.