Mounika T.

Role: Regulatory Submission Publisher at Freyr Solutions
Location: Hyderabad, IN
LinkedIn followers: 500 followers

OperationsView LinkedIn profile

About Mounika T.

An experienced and highly skilled Regulatory Submission Publisher and QCer with extensive…

Experience

Regulatory Submission Publisher
Freyr Solutions
Aug 2022 — Present · Hyderabad, IN
Regulatory Submission Publishing for US, EU, Swiss, UK, GCC, ROW, Canada, AU etc. Compilation, publishing, and technical quality control of regulatory dossier (Document Level & Submission Level Publishing).2. Compilation, Validation and Submission of eCTD dossiers for IND, NDA, BLA, Annual Reports DSUR, PSUR, PADER, PBRER, Adpromo Submission for US Market & Variations, Marketing Authorizations encompassing MRP, DCP, National, Centralised procedures for EU Market.3. Publishing of high-quality dossiers, QC of published dossiers and delivery of submissions in eCTD, Nees, paper format.4.Published and submission of DSUR documents via CTIS4. Handles various tools such as VEEVA-VAULT, eCTDXpress, Lorenz Docubridge, Insight Publisher, ISI Toolbox, ISI Publisher, Lorenz eValidator etc.5. Building eCTD sequence and backbone, arranging ICH as well as Regional Follow electronic naming convention as per ICH naming guidelines. publishing sequence and validation, rectifying all the errors and best practices.6. Technical quality control of published output before dispatching to the HAs. Successful transfer of US, EU, UK submissions through USFDA, CESP, EMA, MHRA and national submitting portals as relevant and sharing the receipt and acknowledgement for client records.7. Archiving all the dispatched submissions and accurate record keeping of various dossiers as per LOC and company standard operating procedure.8. End to end continous co-ordination with Requester, Local operating authority and stakeholders presents globally depending on the submission country.

Contact information

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Current company

Razorpay

Software Development · 4K employees · Bangalore, Karnataka, India

Power your finance, grow your business. Razorpay is India’s first full-stack financial solutions company. We are on a mission to enhance the payment experience of over 300 million end consumers. And in doing so, we aim to enable Indian businesses - big and small - accept payments digitally with minimal effort and maximum ease. Razorpay has grown from being a payment gateway provider to a solutions-driven organization boasting of an extensive products suite to accept and disburse payments as well as raise capital and park money. In a nutshell, we fit into every nook and corner where your business touches money. #OutgrowOrdinary We identify ourselves as disruptors in the digital payments space and our vision is to power the financial ecosystem for other disruptors. Like attracts like and Razorpay actively looks to partner with established companies and startups that have either broken the glass ceiling in their industry or are set to. The Razorpay Product Suite today comprises verticals, along with Payment Gateway, like Payment Links, Payment Pages, Subscriptions, Smart Collect, Route, Razorpay Capital, RazorpayX, Payroll and Thirdwatch. Razorpay was started in 2014 by two IIT Roorkee alumni, Harshil Mathur and Shashank Kumar. Just a short few years later, Razorpay has evolved into a 800-odd strong organization with some of the best talents in the country helping some of the best companies manage their money movement seamlessly. Certified cool We are a bunch of spirited, ambitious and fun folks. And no, we’re not saying this ourselves--leading institutions have recognized Razorpay for the high trust and high-performance culture that we maintain. Our strength lies in the people we are and we go to great lengths to nurture a family of coders, designers, sellers, marketers, analysts, writers, runners, photographers, gamers, tinkerers, and above all, people who are dreamers and doers at the same time. Be a part of our exciting journey.

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