Vishnu Priya

To obtain a sound position and to succeed in ever challenging field of Regulatory affairs, where I can apply the skills that have learn from the previous role and current from the team to which I will be member and want to shape myself as an asset to both the organization as well as add values to my skill assets.

Global Label Specialist - Sandoz

(2021-01)

• Screen and maintain Database, SharePoint and Health authority websites followed by evaluation
• Coordinate to update the core texts SmPC/PILs/labelling for EU registration procedures MRP/DCP/CP in English for variations and renewals & technical support for global Labeling Manager
• Coordinate translation for CPs & ensure in-time handover of variation package response documents to submission team. Interaction with COs to timely submission.
• Ensure patient safety through timely and adequate QC reviews for all CDS updates/periodic regular reviews/first version and CDS reinstallation of the core safety information of marketed products.
• Review and comment on internal or external guidelines and regulations and regulator, safety and legal topics.
• Supporting compliance manager in SOP management, audits/inspection/deviations and oversee training matrix.
• Timely communication with HA on HAQ/DL
• Perform originator review to align with innovator labels & initiating the Work sharing for Nationally registered molecules in European region
• Active role in PSUR activity & hands on experience on different tools as per business requirements
• Support regional labelling projects, interaction with cross functional teams (patient safety, medical team) as to drawn conclusion on safety variations as per work demand
• As needed mentoring the new team/colleagues and active role in process development (i.e WPs, SOP update)

Junior Associate in MPR-LBL Global Labeling and Artwork - Freyr

(2019-01 - 2021-01)

• RPI creation of base document for MAA and variations
• Gap Analysis as required in MS WORD
• Performing Regional Prescribing Information (RPI: including PI, leaflet & IFUs) as appropriate for submission and prior to artwork creation to include but not limited to:
• Proofreading, formatting, alignment to regional templates, client reference guide
• Handling document system for client (in client specific tool)
• Perform following activities with respect to US Artwork Review:
• US labeling Artwork Review (proof reading/QC) against the Source text in document management system only for content check
• Perform following activities with respect to US labeling:
• Redline the scrubbed version using USPI
• US Post HA Approval Activity:
• Create and finalize cumulative redlines for labeling documents
• Prepare biosimilar product labels:
• Prepare side by side label comparison (Biosimilar, MAH changed labels)
• Monitoring updates for biosimilar products and further drafting the label to redline version
• Perform following activities with respect to EU Labeling. Linguistic review:
• Post approval activity – EU minor labeling
• QC prior to review, processing comments, preparing of final translation submission (redline clean, bookmarks, PDFs)
• QC of ROW translation labeling documents - Prescribing and Patient Information to be in line with Translation QC process
• Collaborate/interact with team members and sharing thoughts, ideas, and solutions to executive the task and meet the quality of deliverables and for project development

M. Pharmacy - Pharmacology (2017-01 - 2019-01)

B. Pharmacy (2013-01 - 2017-01)