Experience

iMEDGlobal Corporation

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Regulatory Affairs Associate

  • May 2018 - Present

  • Responsible for author, review, and submission of CMC variation packages (Type IAIN, IA, IB, Type II) and Renewals in EUmarket. • Responsible for author, review, and submission of HAQ responseswith suitable justification. • Co-ordinate with the all stake holders/ site (internal & external manufacturing sites) to arrange the documents required for submission. • Kick off meetings for troubleshoot the issues (like right documents, key issues, risks in submissions & timeline negotiations) with clients. • Handled global change controls for multiple markets & products. • Handled the tools like ARIS, DOCUMENTUM (First Doc), CONNECT, SYMPHONY, REG POINT and CEDMS.



Kinapse

• United Kingdom
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Senior Regulatory Affairs Associate

  • Oct 2015 - May 2018

  • Handling of post approval life cycle management activities (Renewals, Variations, Change controls, Additional doc. Requests& HAQs) for Europe RA–Eastern European Countries and Emerging markets. • Regulatory impact analysis of the changes (Administrative & Quality-CMC) occurring at product and/or site level & act accordingly to ensure compliance with global regulatory requirements. • Author and reviewhigh-quality CMC documentation with regulatory compliance in agreed timelines for the HA submission. • Provide input and support to assist with process implementation, share/test ideas informally with clients. • Provide quality assurance and undertake or assist in training and mentoring of team members depending upon project requirements. • Experience in handling of internal audits, training lead for the onboard of new joiners for my project. • Experience in using various client systems like RCAM(First Doc), eDossiers,CONNECT, DOCUBRIDGE, Red Compass/RSP, Orion/Cognos Reports etc.



DDReg Solutions Pvt. Ltd.

• Gurgoan, New Delhi

• Regulatory Associate

  • Jun 2013 - Jul 2015

  • Responsible for pre-submission as well as post-submission activities (Quality-CMC/ Variations/ Renewal applications) for the Emerging markets. • Responsible for author (CTD, ACTD and Country Specific Format), review, and submission of high-quality CMC (Module 1, 2&3) regulatory compliance documentations for HA submission. • Responsible for author, review, and submission of HAQ responses with suitable justification. • Responsible for author, review, and submission of CMC variation applications (Type IAIN, IA, IB, Type II) for assigned EU projects. • Working for Europe RA – Co-ordination with customers for the registration of products, Identification of variation category, Module1 documents submission to customers, tracking of submitted & approved variations. • Maintenance of variation submission tracking and approval database to enable timely and compliant implantation of license updates. • Responsible for product life cycle management (End to End Process) for assigned projects.