Snehal Potdar
PLEASANTON,CALIFORNIA
Summary
Well-organized and diligent Regulatory Affairs Specialist adept at coordinating and tracking regulatory-related actions. Highly successful at keeping on top of changes in requirements to maintain flawless compliance. Offering 12 years' experience in Regulatory Operations and looking for a challenging new role.
TECHNICAL PROFICIENCY
TOOLS: Veeva Vault | ISIToolbox | Core-Dossier | Firstdoc | eCTDXPress | Insight Publisher | TrackWise | DiaDoc | SharePoint
REPORTS PUBLISHED: CSR | NCS | Module 2 Summary Document | Drug Safety Report (PSUR, ASR, SSR) | DRAM | NeeS Protocol | IB | Annex | Literature Reference
Overview
13
13
years of professional experience
Work History
REGULATORY AFFAIRS SPECIALIST | REGULATORY OPERATIONS
Nektar Therapeutics
San Francisco, CA
02.2019 - Current
- Responsible for supporting Regulatory Affairs Department across a number of company-sponsored projects
- Primarily responsible for creation, assembly, publishing, and verification of both major and routine regulatory dossier submissions to FDA health authorities, including IND safety reports, DSUR, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Responses, etc
- Under supervision, supported EDMS migration to Veeva Vault
- Responsible for Archiving and maintaining US and Non-US regulatory submissions and correspondence for company-sponsored projects, and all company-related sections for partner-sponsored projects in Veeva Vault.
- Supports compilation, formatting, review, and hypertext linking, of submissions to FDA in eCTD (electronic Common Technical Document) format and ensures that navigational tools are functional
- Prepares final documents for review by Regulatory Affairs and submission to health authority
- Ensures that submissions meet format, publishing and submission requirements applicable for regulatory requirements (i.e., US, ICH)
- Supports the development of internal standards to ensure consistency across projects
MEDICAL WRITER | TECHNICAL EDITOR
Roche Molecular Diagnostics
Pleasanton, CA
10.2015 - 02.2019
- As a part of the Medical Writing group, develop draft reports such as CSRs, Protocols, and CVPs for Clinical Utility and Reproducibility studies for submissions utilizing templates
- Facilitate efficient business process operations by closely collaborating with various groups including Biostatistics, RA, Data management, and CRAs
- Arrange and lead regular review meetings with internal stakeholders in order to provide finalized reports in timely manner
- Collaboration with management team to provide training to Medical Writers to ensure best working practices are maintained
- Perform literature searches/reviews and research current guidelines as necessary to gather background information and training for development of documents
- Manage review and approval process of clinical submissions documents, writing documents, generating consensus among reviewers, and facilitating discussions
- Advising on resource utilization, efficiencies and timelines
- Ensure proper and accurate report completion through provision of formatting services including editing, proofing, converting text and graphics, bookmarking, hyperlinking, rendering, compilation
- Manage document lifecycle by controlling desired quality standards of reports and conducting SOP revisions applying TrackWise
- Tools: ISIToolbox, DiaDoc Word templates, Adobe Acrobat ver10
REGULATORY, OFFSHORE PROJECT LEADER
Cognizant Technology Solutions, AFFAIRS PUBLISHING
Mumbai
08.2014 - 07.2015
- Managed offshore regulatory publishing operations by supervising a team of 20+ associates as well as coordinating daily inflow of reports and timely delivery while working with offshore part of only one client, Boehringer Ingelheim, Germany
- Performed quality assurance of document control systems and procedures by maintaining SLAs and providing consistent reporting to client
- Directed efforts of resource planning, organization, and coordination of all internal and external operations supporting Client regulatory team and forecasting activities within domain
- Led Cognizant Technology Solutions (CTS) team by conducting recruitment and selection of staff, providing regular internal and external team meetings, and managing attrition
- Effectively directed document flow, collection, and reviewing as well as coordinated clarification activities according to
- Regulatory Guidelines while providing quality delivery and metrics reporting
- Ensured timely project's completion through conduction of ongoing performance monitoring, talent and motivation management of team, and strict compliance with SOPs
- Formed and maintained long-term business relationships with key stakeholders by discussing essential issues and reporting on progress directly to CTS Project Manager and Client Alliance Managers
- Consistently ensured highest quality standards while handling most complex studies and critical molecules of domain
- Monitored team performance and report on metrics, motivated team members, identified training needs and provided coaching
- Significantly contributed to developing new business opportunity as technical expert to CTS by working on RFI and RFP, spearheaded conversion of bid into business.
Cognizant Technology Solutions
Mumbai
06.2011 - 08.2014
- Performed quality assurance and control of publishing procedures of critical report's references while checking quality of published reports including CSRs and CSR equivalents as per the eCTD requirements
- Oversaw team performance effectiveness and completed quality analysis for published reports following quality checklist
- Collected publishing activity data for each published report in Tracking Sheet Template
- Served as subject matter expert for all projects by offering solutions to publishing-related inquiries to other team members
- Utilized eCTDXPress application for hyperlinking and publishing regulatory reports
- Tools: ISIToolbox, eCTDXpress, Insight Publisher, Adobe Acrobat ver10
DOCUMENT SPECIALIST
Tata Consultancy Services
Mumbai
05.2009 - 06.2011
- Performed offshore report publishing, compliance checking, and publishing of reports including clinical and non- clinical reports, protocols dual protocols, investigator brochures, drug safety reports (PSUR, ASR SSR), DRAM, investigator packages, NeeS documents, annexes and literature references
- Tracked publishing activity information for published reports in the Tracking Sheet Template
- Performed accurate document formatting, editing, proofing, creating and manipulating complex tables, converting text and graphics, legacy conversion, scanning, bookmarking, hyperlinking, rendering, volumation, pagination, and formatting of simple submissions
- Conducted quality analysis of published documents and ensured documents' adherence to the RAPID
- PDF Compliance Tool Guideline for RSG Publishers gcp_gui000045 and Compliance Checklist for RAPID
- Word Documents
- Coordinated document management operations including file transfer, storage, tracking, and archival
- Acted as a point of contact for alliance liaisons and authors regarding report quality analysis issues addressing.
Education
Post Graduate Diploma - Pharmaceutical Management
Institute of Clinical Research India
Mumbai2007
Bachelor of Science - Biotechnology
Nagpur University
2006
Skills
- Regulatory Operations
- Regulatory Affairs Publishing
- QA and QC
- Compliance Check
- ECTD Format
- Staff Supervision
- Document Control
- Training and Coaching
- Communication
- Problem-Solving
- Multi-Tasking
- Result Driven
Timeline
REGULATORY AFFAIRS SPECIALIST | REGULATORY OPERATIONS
Nektar Therapeutics
02.2019 - Current
MEDICAL WRITER | TECHNICAL EDITOR
Roche Molecular Diagnostics
10.2015 - 02.2019
REGULATORY, OFFSHORE PROJECT LEADER
Cognizant Technology Solutions, AFFAIRS PUBLISHING
08.2014 - 07.2015
Cognizant Technology Solutions
06.2011 - 08.2014
DOCUMENT SPECIALIST
Tata Consultancy Services
05.2009 - 06.2011
Post Graduate Diploma - Pharmaceutical Management
Institute of Clinical Research India
Bachelor of Science - Biotechnology
Nagpur University
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