Experience

Titan Laboratories (P) Ltd.

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• • Apr 2021 - Present

• • Apr 2021 - Present

  Brazil, Mexico, Australia, New Zealand, Europe, ROW



Crescent Pharma Ltd

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Specialist

  • Nov 2019 - Aug 2020



Genpact Pharmalink

• Mumbai, Maharashtra, India

• Lead Consultant

  • Jul 2017 - Nov 2019

  CMC Renewals and Variations for EU and ROW markets. Providing support to the client and dealing directly with the Authorities. CMC Renewals and Variations for EU and ROW markets. Providing support to the client and dealing directly with the Authorities.



Precise Chemipharma Pvt Ltd

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Head-Regulatory Affairs

  • Sep 2016 - Jul 2017

  Handling Registration, Variation & Renewal Activities in the following countries: CIS: Russia, Ukraine, Kazakhstan, Armenia. Asian: Singapore, Malaysia, Cambodia, Vietnam, Myanmar, Philippines, Thailand, SriLanka, Taiwan, HongKong. Gulf: Oman, Jordan Latam: Brazil, Mexico, Sudan, Kenya. Handling Registration, Variation & Renewal Activities in the following countries: CIS: Russia, Ukraine, Kazakhstan, Armenia. Asian: Singapore, Malaysia, Cambodia, Vietnam, Myanmar, Philippines, Thailand, SriLanka, Taiwan, HongKong. Gulf: Oman, Jordan Latam: Brazil, Mexico, Sudan, Kenya.



Receta Pharmaceuticals India Pvt Ltd

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Manager Regulatory Affairs

  • Dec 2015 - Nov 2016

  Preparation & Review of the dossiers as per the current prescribed guidelines of the respective regulatory authorities. Registration of Pharmaceuticals in International markets (ASEAN Countries). Registration of Pharmaceutucals in Thailand, Malaysia, Vietnam, Cambodia, Shri Lanka, Philippines, Myanmar and Latin America. To provide regulatory guidance and expedite responses to regulatory authorities. Review of the quality and analytical data as per the pharmacopoeia, specification, MOA, STP, batch records, Stability, Finished products/ Packaging material data for the purpose of compilation of the dossier. Review of documents required for Regulatory agencies (viz Analytical reports, Processvalidation protocols , Process validation reports, Pharmaceutical Development Reports, Protocols & Stability Data. Preparation /Review of labeling of packaging material. Pack inserts the finish formulation marketing materials, promotion materials under supervision. Preparation and review of the SPC, package insert and labeling information. Show less



Famy Care Ltd., Mumbai

• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Asst Manager

  • May 2014 - Mar 2015

  Handling deficiencies raised by the UK-MHRA as well as Customer queries. Consulting clients on their filing and regulatory planning, guiding and advising on creating required documentation and studies based on ICH. Timely and effective query response raised by regulatory authorities. Handling of change control proposals and if required implementation of changes in licenses through variation and notification. Responsible for independently handling DCP, MRP and National fillings. Handling deficiencies raised by the UK-MHRA as well as Customer queries. Consulting clients on their filing and regulatory planning, guiding and advising on creating required documentation and studies based on ICH. Timely and effective query response raised by regulatory authorities. Handling of change control proposals and if required implementation of changes in licenses through variation and notification. Responsible for independently handling DCP, MRP and National fillings.



USV PRIVATE LIMITED

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Executive

  • Apr 2010 - Jun 2013

   Responsible for dossier filing in EU and CANADA with formulation exposure to solid dosage forms and parenterals  Submission of registration dossiers in CTD format as per ICH guidelines for filing application with various Regulatory Agencies in European continent and Health Canada.  Effective query reply raised by various Regulatory Agencies in European continent  Review and Authorization of technical documents like FPS, RMS, Stability data, Art works etc.  Handling of change control proposals and if required implementation of changes in licenses through variation and notification.  Responsible for independently handling DCP and National fillings Show less



Ipca Laboratories Limited

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Executive Regulatory Affairs

  • Jun 2010 - Mar 2011

  Dossier Compilation for Module 1 to Module 5 Query Handling, DCP's, MRP and National Fillings Dossier Compilation for Module 1 to Module 5 Query Handling, DCP's, MRP and National Fillings



Vikhroli

• Cipla Pharma R&D

  • May 2008 - Jun 2009

   Knowledge of TGA, EMEA and ICH Guidelines.  Dossier Compilation in CTD format and submission to TGA of various dosage forms (Tablets, Capsules, Oral Suspension, Nasal Spray, Injections).  Complying deficiencies raised by the regulatory agencies before registration of the product.  Work closely with Regulatory Operations to compile and review post-approval submissions for completeness and quality.  Regulatory requirements in involving technology transfer, optimization batches, bio batches, scale up and validation batches. Show less



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr Scientist Grade III

  • 2005 - 2007

  -Performing tests and experiments of moderate complexity with supervision. -Maintaining analytical instruments and laboratory. Qualifying instruments from audit point of views. (like US FDA , GQO , EMEA , WHO etc….) . -Participation in management of stability samples and maintenance of laboratory database -As required, coordinates and manages critical laboratory functions, such as the stability program, or administration of the laboratory database , or technical writing. -To prepare method validation protocols, qualification summary reports SOP's etc. Independently managed Audit conducted by the Global Team of Novartis OTC R&D. Qualification knowledge on Balances, Dissolution testers. Show less



Nicholas Piramal

• • 2004 - 2005

• • 2004 - 2005



SUN PHARMA

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Officer

  • 2000 - 2004

  • Working on ANDA projects. • Take part in method development activities. • Handling of out or specification (OOS) Results. • Stability studies of Formulation Development samples as per ICH Guidelines. • Preparation of Protocol (Method development, method validation). • Preparation of guidelines and standard operation procedure (SOP) and Standard testing procedures (STPs). • Working on excipients and API's (Active Pharmaceutical Ingredients) and Water Analysis. • Review and Compilation of data. Show less