Mayakrishnan Yadav

About Mayakrishnan Yadav

I am an experienced Regulatory Affairs Professional with a demonstrated history of working in the Pharmaceuticals, CRO and Service Provider industries for around 18 years. I am skilled in following: • Project Management, People Management, Talent Management, Performance Management, • Regulatory Operations (supported Regulatory Affairs (RA) team on routine operational works), • Document Lifecycle Management (well-versed in web-based Electronic Document Management System (EDMS) functions), • Document Formatting (well-versed in using ISIWriter Tool and MS Word functions), • Report Publishing with electronic navigations (well-versed in using ISIToolBox 6.2 and Adobe Acrobat X Pro functions), • Acted as SME to business partners, IT and system vendor for implementing new web-based EDMS. Also, supported in drafting UAT scripts, testing, execution, verification of migrated data, and implementation, • Delivered training in new web-based EDMS (used for managing documents electronically), ISIToolBox 6.2 (used for processing PDF documents with electronic navigations to ensure submission ready), and ISIWriter Tool (used for document authoring and formatting) to various regulatory affairs professionals across the globe, • Acting as site business administrator to business partners and system vendor for any system/document issues tracking and resolution. • Document Template Management (managed document authoring template library and template developments for global and regional team, able to manage/control master site template), • Dossier Template Management (managed dossier template structures for CTD and non-CTD following countries of APAC, MEAP, CIS, Turkey, Russia, LATAM for product areas: Medicinal Products, DMF, Food Supplements, Cosmetics, Ayurveda and Medical devices), • Submission Management (supported RA team in submission compilation and building registered position activities), • Registration Management (well-versed in lifecycle management of regulatory applications/activities), • Submission Publishing (used ISIPublisher, Lorenz DocuBridge, and Lorenz validator), • SharePoint Management (managed SharePoint ownership responsibilities and developed form for tracking the projects and form for business partners to send request, navigations, metrics, collaboration area and home page with relevant content for business partners to know list of services they can expect from Operations team), • Well-versed in MS Excel functions and managed data to present the metrics to the management, • Traveled to Germany, US, Russia and Croatia for supporting business objectives.

Experience

1. Manager Regulatory Operations (Document Operations and Pma) - Global Regulatory Affairs

   Abbott

   May 2020 — Present · Mumbai, IN

Education

• TCS

  SAS Programming

  2010 — 2010

• N.G.Acharya & D.K.Marathe College

  B.Sc., Chemistry

  2001 — 2004

• Madurai Kamaraj University

  M.Sc., Chemistry

  2007 — 2008