Narendra Chavan Email and Phone Number
Narendra Chavan work email
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Narendra Chavan personal email
I’m a Regulatory Operations Manager with a passion for improving submission standards with more than 13 years of experience in the Pharmaceutical industry.I have successfully implemented two fast paced central teams for EU, Health Canada and US Submissions (Teva & SPARC) in India for Initial Submissions like IND, NDA,BLA, ANDA, IMPD, MAA and life cycle management of application, CoPP. Experience on Publishing tools like Freyr Submit, Lorenz Docubridge, Liquent Insight Publisher and Plug-ins like ISI Toolbox, Debenu PDF Aerialist, Validations tools like Lorenz Validator. e-DMS and SharePoint.I'm a hands-on manager, with the benefit of experience which includes all aspects of eCTD publishing from coordinating and planning to compilation, validation and dispatch. In addition I have experience of recruitment, performance management and career development.
Sun Pharma Advanced Research Company Ltd.
View- Website:
- sunpharma.in
- Employees:
- 563
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Manager- Global Regulatory Affairs OpsSun Pharma Advanced Research Company Ltd. May 2017 - PresentMumbai, Maharashtra1. Includes all duties of a Regulatory Affairs- Operations (Publisher)2. Working on submission teams and with functional areas to produce Regulatory submissions.3. Collaborate with RA and project managers4. Effective timeline management and communications relative to submission components.5. Use Regulatory Affairs systems™ and tools which supports the e-DMS & SharePoint.6. Publish, review, submit and archive Initial IND, NDA, Amendments, Safety Reports & routine life cycle management of eCTD submissions7. Track submission activity (i.e. status, audit trails) and provide reports to upper management.
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Assistant Manager - Ra PublishingTeva Pharmaceuticals Aug 2015 - May 2017Mumbai, Maharashtra1. Provide routine publishing support to Global Regulatory Activity.2. Manage the daily activities and workload of site publishing team and ensuring that individuals are trained and comply with all SOPs and internal publishing standards.3. Coordinate and lead major/complex and routine/lifecycle management eCTD submission projects.4. Prepare and deliver performance management and career development plans for staff.5. Participate in Global Regulatory Operations management team meetings and other GRO project teams 6. Perform performance management activities including goal-setting, development plans and annual appraisals for the team.7. Lead or participate in cross-site project teams working on initiatives as defined by the RSM Senior Leadership. -
Senior Regulatory AssociateFreyr Solutions Aug 2014 - Aug 2015Hyderabad, Telangana1. Responsible for assembly, compilation and dispatch of US FDA, EMA and GCC in paper NeeS and eCTD format.2. To act as a point of communication between with the Project Personnel and the Sponsor in order resolve queries (if any) related to project activities.3. Publish Submissions including Original IND Application, ANDA, Amendments, Protocol Amendments, DMF, DSUR, PSUR, Annual reports, CMC updates etc.4. Lead Publisher for MAA lifecycle publishing including but not limited to Variation Type IA, IB, II, supplemental info, PSUR and responses submitted to EMA and member states. 5. Adhering to quality control procedure and standards related to submission publishing.6. Life Cycle Management of Drug Product (creating life cycle submission).7. Support compliance with worldwide submission regulations and guidelines. -
Senior Research Associate In Regulatory Affairs & Project ManagementSynapse Labs Pvt. Ltd. Dec 2010 - Jul 2014Pune, Maharashtra1. Good knowledge of ICH/ regional eCTD guidelines2. Compliance checking, linking, Bookmarking, QC/ review of documents, Rendering Multiple Documents to PDF, Creation of external links, for Module-5 (Clinical Study Report) in eCTD format.3. Compilation of NeeS, Compilation of paper submission, QC/ review of dossier & Validation.4. Good working knowledge of less complex tools/systems used in support of publishing processes, in particular Adobe Professional IX, ISI Toolbox and Validation Tools etc.5. To act as a point of communication between with the Project Personnel and the Sponsor in order resolve queries (if any) related to project activities.6. Good understanding of existing regulatory agency standards and formats for submission and ensure that the Clinical Study Report publishing output meets these requirements.7. Archive hard copy and electronic files of the final CSR or summary document as appropriate.
Narendra Chavan Skills
Narendra Chavan Education Details
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4 Gpa - B -
Higher Second Class -
First Class With Distinction
Frequently Asked Questions about Narendra Chavan
What company does Narendra Chavan work for?
Narendra Chavan works for Sun Pharma Advanced Research Company Ltd.
What is Narendra Chavan's role at the current company?
Narendra Chavan's current role is Manager - Global Regulatory Affairs Ops at Sun Pharma Advanced Research Company Ltd..
What is Narendra Chavan's email address?
Narendra Chavan's email address is na****@****o.co.in
What schools did Narendra Chavan attend?
Narendra Chavan attended Savitribai Phule Pune University, Pravara Institute Of Medical Sciences, Ahmednagar, Savitribai Phule Pune University.
What are some of Narendra Chavan's interests?
Narendra Chavan has interest in Children, Environment, Education, Poverty Alleviation, Science And Technology, Disaster And Humanitarian Relief, Human Rights, Animal Welfare, Health.
What skills is Narendra Chavan known for?
Narendra Chavan has skills like Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Ectd, Validation, Regulatory Requirements, Ich Gcp, Clinical Research, Regulatory Publishing, Quality Control, Standard Operating Procedure, Document Lifecycle Management.
Who are Narendra Chavan's colleagues?
Narendra Chavan's colleagues are Jay Adhyapak, Anil Deshantri, Jerry Varghese, Denny Sebastian, Muzaffar Ali, Phd, Kamal Shah, Rana Hiral.
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