Experience

Crius Group of Companies

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Manager

  • Jan 2018 - Present



Shivek Labs Limited

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Executive

  • May 2016 - Dec 2017

  Its a pharmaceutical company and our sole concern is human life. 'Ethical' describes both the drugs it make and the values we have upheld for many generations. Its a pharmaceutical company and our sole concern is human life. 'Ethical' describes both the drugs it make and the values we have upheld for many generations.



Nestor Pharmaceuticals Limited

• Gurgaon, India

• Senior Executive

  • Apr 2015 - May 2016

  Compiling, reviewing and submission of dossier as per country guidelines’ for product registration in CIS countries, ASEAN countries and Latin America (mainly worked on Ukraine, Philippines, Laos, Cambodia, Myanmar, Vietnam, Tajikistan, Nigeria, Ghana and Cameroon.)  Regulatory submission in different formats ACTD and CTD.  Understanding of all Pharmaceutical Documentation required in the industry(i.e. validation, BMR/BPR, SOP and specifications, MFR, stability protocol/reports.  Liaison with regulatory authorities for technical queries.  Art work approval regarding leaflet, primary and secondary packing material. Show less



Protech Biosystems Pvt. Ltd.

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Executive

  • Dec 2013 - Apr 2015

   Compiling, reviewing and submission of dossier as per country guidelines’ for product registration in CIS countries, ASEAN countries and Latin America (mainly worked on Ukraine, Philippines, Laos, Cambodia, Myanmar, Vietnam, Tajikistan, Nigeria, Ghana and Cameroon.)  Regulatory submission in different formats ACTD and CTD.  Understanding of all Pharmaceutical Documentation required in the industry(i.e. validation, BMR/BPR, SOP and specifications, MFR, stability protocol/reports.  Liaison with regulatory authorities for technical queries.  Art work approval regarding leaflet, primary and secondary packing material.  Knowledge of applying for legal documents like free sale certificate and COPP.  Handling and responding to all the product specific queries arising from various countries.  Packaging and export for required documents in connection to the preparation of dossier. Show less



Belco Pharma

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Executive Drug Regulatory Affairs

  • Aug 2010 - Dec 2013

   Responsibility of applying for legal documents like New product permissions, WHO renewal, Mfg Licence renewal and COPP at H.P FDA.  Team handling (4-5 DRA Executives) and prepare work schedule chart to complete project on time.  Regulatory submission in different formats ACTD and CTD.  Understanding of all Pharmaceutical Documentation required in the industry (i.e. validation, BMR/BPR, SOP and specifications, MFR, stability protocol/reports.  Liaisoning with regulatory authorities for technical queries.  Art work approval regarding leaflet, primary and secondary packing material.  Handling and responding to all the product specific queries arising from various countries.  Responsibility of sending sample courier and documents like MSDS, packing Invoice etc to courier service. Show less