Experience

Kusum healthcare, delhi, india

• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Regulatory Affairs - Sr. Executive

  • Feb 2014 - Present

  • Compilation and review of dossiers CTD format for finished pharmaceutical products (Tablets/Oral suspension/Oral Solution) for Ukraine and CIS countries. Sole responsibility in RA New Delhi office for dossier filing of finished formulations which are manufactured in Kusum Pharm LLC Ukraine plant and query related issues. • Review of Drug Master Files (DMF) and arrangement of technical as well as legal and other documents need for API registration/re-registration and variation filing. Coordination with API manufacturer for document related issues. • Respond to the queries raised by the different regulatory authorities within a defined time frame. • Review of Bioequivalence studies; clinical, analytical and coordination with CRO in order to submit BE report and BE related queries in Ukraine, Kazakhstan MoH. • To maintain the backup for the dossiers/documents that has been sent to regulatory authorities as well as documents which are received from QA/QC for dossier compilation. • To prepare and update the database of monthly record/status of the dossiers/documents. • To coordinate with Ukraine plant QA, QC and regulatory counterpart to facilitate document availability. • Additional work like review of artwork, review of packaging insert, compilation of technical information sheets for ASEAN countries. Show less



Ind-Swift Limited

• India
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Regulatory Affairs Executive

  • Oct 2012 - Jan 2014

  • To review & compile dossiers (ACTD, CTD and country specific) for finished pharmaceutical products (Tablets, injections, Dry powders & capsules) for ROW, CIS, LATAM & Asian Countries. • To respond to the queries raised by the different regulatory authorities within a defined time frame. • To maintain the backup for the dossiers/documents that has been sent to regulatory authorities/ international marketing department. • To prepare and update the database of monthly record/status of the dossiers/documents/samples sent. • To coordinate with QA, QC to facilitate document availability. • To prepare and review the dossiers for outsourced products. • To prepare Packaging Insert and review of artwork. • To collect and preserve the guidelines of different countries for the registration of pharmaceutical products. Show less



Nectar Lifesciences Limited

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Working as Sr. Officer - Regulatory Affairs

  • Mar 2012 - Oct 2012

  • To prepare, review & compile dossiers (ACTD, CTD and country specific) for finished pharmaceutical products (Tablets, injections, Dry powders & capsules) for ROW market. • To respond to the queries raised by the different regulatory authorities within a defined time frame. • To co-ordinate with QA/QC (formulation)/RA (API)/ and International marketing dept. personnel. • To maintain the backup for the dossiers/documents that has been sent to regulatory authorities/ int. marketing dept. • To prepare and update the database of monthly record/status of the dossiers/documents/samples sent. • To check Artworks developed for ROW market. • To collect and preserve the guidelines of different countries for the registration of pharmaceutical products. • To arrange product samples from production dept. and sent to marketing dept. as per their demand/guidelines. • To prepare and review the dossiers for outsourced products. Show less



Acme Formulation

• Regulatory Affairs

  • Jan 2010 - Mar 2012

  • Preparation of Dossiers for ASEAN countries like Myanmar, Cambodia, Vietnam; African Countries like Nigeria, Ghana, Tanzania, Uganda, Zambia, Kenya; LATAM countries like Nicaragua, Guatemala, El-salvador. • Coordination with different departments like production, quality control, quality assurance, PM stores for required documentation. • Review of BMR, BPR, Validation protocols, Stability protocols and reports, COAs, specifications and STPs. • Compilation and review of package inserts for dosage forms. • Collection of information like Clinical studies, Pharmacology, Biopharmaceutical aspects from internet and compilation as per requirement in dossiers. • IPQA activities Show less



Sarvotham Care Pvt. Ltd.

• Sarvotham Care - Manufacturer of Amway's product

  • Oct 2009 - Jan 2010