Narendra Chavan Email & Phone Number

Mumbai, Maharashtra

1. 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.

Mumbai, Maharashtra

1. 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.

Hyderabad, Telangana

1. 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.

Pune, Maharashtra

1. 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.

Pg Certificate Course, Clinical Research And Clinical Data Management, 4 Gpa - B

Master'S Degree, Medical Biotechnology, Higher Second Class

Bachelor'S Degree In Science, Botany, First Class With Distinction