Experience

Morningside Healthcare Ltd

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Manager

  • Apr 2019 - Present



Cipla

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Krushida

  • Aug 2004 - May 2019

  Executive in Regulatory Affairs department handling Europe

• Deputy Manager

  • Jan 2017 - 2018

  Responsible for preparing regulatory strategy for products in pipeline for US. Review of the CMC documents for ANDA, deficiency responses. Compilation and publishing ANDA's, Final Approval Request, Deficiency responses Annual Reports.

• • Worked as Management staff with Cipla Limited in Vikhroli Manufacturing Unit in Stores Department

  • Aug 2004 - Oct 2006

  As a fresher was involved in inventory management in stores department at Cipla,Vikhroli Manufacturing Plant. Worked in shopfloor and witnessed WHO audit.



Cipla Lt

• Mumbai Area, India

• As management staff

  • Jun 2013 - Dec 2016

  • Responsible for New Registration for Cipla Own-Registration Business, In-Licensing Business in Europe . • Independently responsible to handle the preparation, compilation, review and submission of high quality regulatory dossiers to Health Authorities, in support of new marketing authorization applications via National, MRP, DCP, RUP and Line Extensions Procedures. • To support all required processes at various stages leading resulting in timely closure of the procedure and… Show more • Responsible for New Registration for Cipla Own-Registration Business, In-Licensing Business in Europe . • Independently responsible to handle the preparation, compilation, review and submission of high quality regulatory dossiers to Health Authorities, in support of new marketing authorization applications via National, MRP, DCP, RUP and Line Extensions Procedures. • To support all required processes at various stages leading resulting in timely closure of the procedure and subsequent national approvals to ensure timely launch for Europe. • Review of dossiers and deficiency responses before final submission to agency. • To liaise & make frequent interactions with Competent Health Authorities and if required other applicable departments within the organization to discuss and provide right solutions to regulatory issues or problems. • Total 15+ MR procedures and 20+ nationals including Serbia, Bosnia, Macedonia, Montenegro, Albania and Kosovo have been handled for Cipla. • To perform Online Audit/ Desktop Audit of third party dossier for In-licensing business. • To prepare product offer sheets as required for out-licensing business, registration data sheet for own registration business and marketing strategy notification during procedures to ensure regulatory and business alignment. • Well versed with handling e-CTD software like Educe, EURS validator & Bfarm Validator. • Acted as Europe representative for development of Documentum and Trackwise software for Europe region in Cipla. • To update Regulatory Information in company database and distribution of notifications to Business. And relevant stake holders. Sharing of approved information with manufacturing units. • Preparation of RA strategy for pipeline products for Europe Submission. • Attending Kick off launch meetings to address, discuss and resolve issues relating launches. • To conduct training sessions as allotted, within the EU operation team of Cipla. Show less • Responsible for New Registration for Cipla Own-Registration Business, In-Licensing Business in Europe . • Independently responsible to handle the preparation, compilation, review and submission of high quality regulatory dossiers to Health Authorities, in support of new marketing authorization applications via National, MRP, DCP, RUP and Line Extensions Procedures. • To support all required processes at various stages leading resulting in timely closure of the procedure and… Show more • Responsible for New Registration for Cipla Own-Registration Business, In-Licensing Business in Europe . • Independently responsible to handle the preparation, compilation, review and submission of high quality regulatory dossiers to Health Authorities, in support of new marketing authorization applications via National, MRP, DCP, RUP and Line Extensions Procedures. • To support all required processes at various stages leading resulting in timely closure of the procedure and subsequent national approvals to ensure timely launch for Europe. • Review of dossiers and deficiency responses before final submission to agency. • To liaise & make frequent interactions with Competent Health Authorities and if required other applicable departments within the organization to discuss and provide right solutions to regulatory issues or problems. • Total 15+ MR procedures and 20+ nationals including Serbia, Bosnia, Macedonia, Montenegro, Albania and Kosovo have been handled for Cipla. • To perform Online Audit/ Desktop Audit of third party dossier for In-licensing business. • To prepare product offer sheets as required for out-licensing business, registration data sheet for own registration business and marketing strategy notification during procedures to ensure regulatory and business alignment. • Well versed with handling e-CTD software like Educe, EURS validator & Bfarm Validator. • Acted as Europe representative for development of Documentum and Trackwise software for Europe region in Cipla. • To update Regulatory Information in company database and distribution of notifications to Business. And relevant stake holders. Sharing of approved information with manufacturing units. • Preparation of RA strategy for pipeline products for Europe Submission. • Attending Kick off launch meetings to address, discuss and resolve issues relating launches. • To conduct training sessions as allotted, within the EU operation team of Cipla. Show less



Cipla Limite

• Mumbai Area, India

• As Management staff with Cipla Limited in Drug Regulatory Affairs Department for Europe Market

  • Nov 2006 - Jun 2013

  Job responsibilities during the period Nov 2006 to June 2013: •Compilation & collation of registration dossier (Module I to V) as per EU requirements for Generic Product application into ICH and country specific formats (CTD/NeeS/eCTD) for own registration as well as for the customer-based business in Europe market. •Handled various DCPs, MRPs & National Procedures of registration applications for Europe market for majorly customer-based business. •Verification of dossier/ documents… Show more Job responsibilities during the period Nov 2006 to June 2013: •Compilation & collation of registration dossier (Module I to V) as per EU requirements for Generic Product application into ICH and country specific formats (CTD/NeeS/eCTD) for own registration as well as for the customer-based business in Europe market. •Handled various DCPs, MRPs & National Procedures of registration applications for Europe market for majorly customer-based business. •Verification of dossier/ documents before submission for its correctness and completeness. •Compiling & formatting technical documents for Dossier preparation in eCTD format and responsible for the submission as well, via Common European Submission Platform. •Co-ordination with R & D, ADL, QA, QC etc. to collect the complete set of documents. •To provide adequate regulatory inputs for generations of manufacturing and QA related documents during development to ensure that the data generated on regulatory batches is suitable for submission. •Highly proficient in handling deficiencies and change classification with respect to sterile formulation. •Preparing and sending out project progress reports and raising early alarms on issues that might delay approvals. •Preparation and Status Maintenance of technical agreements with customers •Regulatory support to manufacturing units during customer and agency audits •Handling Post Approval Life Changes and renewals of the marketing authorizations for the Europe market; customer-based business in Europe market •Actively involved in customer launches & maintenance of customer status and submission, approval and variation tracking and database updation to enable timely and compliant implantation of license updates. • Registration of various dosage forms handled for Europe market like Tablets , capsules, Ophthalmic solution, Lyophilized and Liquid injections. Also handled assignments with respect to product registration for New Zealand market Show less Job responsibilities during the period Nov 2006 to June 2013: •Compilation & collation of registration dossier (Module I to V) as per EU requirements for Generic Product application into ICH and country specific formats (CTD/NeeS/eCTD) for own registration as well as for the customer-based business in Europe market. •Handled various DCPs, MRPs & National Procedures of registration applications for Europe market for majorly customer-based business. •Verification of dossier/ documents… Show more Job responsibilities during the period Nov 2006 to June 2013: •Compilation & collation of registration dossier (Module I to V) as per EU requirements for Generic Product application into ICH and country specific formats (CTD/NeeS/eCTD) for own registration as well as for the customer-based business in Europe market. •Handled various DCPs, MRPs & National Procedures of registration applications for Europe market for majorly customer-based business. •Verification of dossier/ documents before submission for its correctness and completeness. •Compiling & formatting technical documents for Dossier preparation in eCTD format and responsible for the submission as well, via Common European Submission Platform. •Co-ordination with R & D, ADL, QA, QC etc. to collect the complete set of documents. •To provide adequate regulatory inputs for generations of manufacturing and QA related documents during development to ensure that the data generated on regulatory batches is suitable for submission. •Highly proficient in handling deficiencies and change classification with respect to sterile formulation. •Preparing and sending out project progress reports and raising early alarms on issues that might delay approvals. •Preparation and Status Maintenance of technical agreements with customers •Regulatory support to manufacturing units during customer and agency audits •Handling Post Approval Life Changes and renewals of the marketing authorizations for the Europe market; customer-based business in Europe market •Actively involved in customer launches & maintenance of customer status and submission, approval and variation tracking and database updation to enable timely and compliant implantation of license updates. • Registration of various dosage forms handled for Europe market like Tablets , capsules, Ophthalmic solution, Lyophilized and Liquid injections. Also handled assignments with respect to product registration for New Zealand market Show less