Summary
Overview
Work History
Education
Skills
Scholastic And Other Achievements
Personal Information
Languages
Affiliations
Disclaimer
Timeline
Generic

Ashwini Naik

Malad West

Summary

Regulatory affairs associate with 8.2 years of experience in ensuring that company products meet current regulatory standards and requirements. Multi-tasking Lead Consultant skilled in RIMS activity and well-learned in Regulatory Affairs . A diverse professional pursuing an exciting position where honesty, agility and resourcefulness will be highly valued. Looking forward to enhance knowledge for professional growth in the field of Pharmaceuticals and healthcare and elevate to higher achievements in career and procure responsibilities that account on the basis of performance and diligent work.

Overview

8
8
years of professional experience

Work History

Lead Consultant - Regulatory Information Management System

Genpact India Pvt Ltd
Mumbai
08.2020 - Current
  • Cross trained for Submission Publishing activity (NEES, eCTD, Concatenated pdf) for LATAM, APAC, EU and EMEA region. Tools used are Liquent Insight(Create Event, Assembly and sequence) and Veeva(archival).
  • Responsible for monitoring daily mails received by Country Regulatory Authority and Publishers and assigning everyday task to team members based on TAT.
  • Undertake RIMS training for new joiners and associates undergoing cross training for RIMS.
  • Resolve queries, discrepancies and find solution for RIMS related activity internally as well as for CRA's.
  • Perform gap analysis and provide plans based off of identified recommendations. Identify loop holes in the Process and Work instructions.
  • Maintain complete understanding of Regulatory Information Management, Product Lifecycle Maintenance and activity specific guidance documents.
  • Regularly interact and co-ordinate with project manager/regional affiliate to ensure accuracy and completeness of data in system
  • Responsible for accurately remediating the existing legacy data, adding new entries and deleting entities within the system (if applicable) so that it is an authoritative source of product registration information which is readily available to the other key processes in Genpact
  • Creating Events on timely manner for submissions.
  • Support global process; executing end-to-end submission packages which includes Event creation, PDS update,Registration update, Event status update, Submissions, Approvals and Withdrawals of records.
  • Set up and carry out the process for Actuals to ensure correct data entered in Regulatory planning tool.
  • Running monthly reports for overdue submissions and approvals and guiding team to obtain the data/rationale from CRA for overdue and updating Regulatory Planning tool.
  • Remediating actuals entered in Regulatory planning tool.
  • Perform Past Due Artwork activity for Overdue Artworks in the system.
  • Received approval for two Lean ideas which helped team to reduce errors and archive data efficiently.
  • Active participation in creating training material for RIMS, Veeva and IDMP for Genpact training portal.

Regulatory Affairs Associate I - Regulatory Information Management System

TEVA Pharmaceutical
Navi Mumbai
12.2019 - 07.2020
  • Maintain complete understanding of Regulatory Information Management, Product Lifecycle Maintenance and activity specific guidance documents
  • Performing internal QC activities and supporting archival of documentation
  • Regulatory interact and co-ordinate with project manager/regional affiliate to ensure accuracy and completeness of data in system
  • Creation, Remediation and Updating of product Application, Events, PDS and Registration details in Regulatory information management system(Liquent Insight) for pharmaceutical, medical devices and consumer healthcare products
  • Updating API details, Excipient details, Packaging details, Shelf life and Storage conditions etc for the Products into repository by referring respective Dossiers and Regulatory Compliance File
  • Responsible for accurately remediating the existing legacy data, adding new entries and deleting entities within the system (if applicable) so that it is an authoritative source of product registration information which is readily available to the other key processes in Teva
  • Ensure Quality and TAT targets are achieved.

Senior Process Associate - RegulatoryInformation Management (Product Lifecycle Management)

TATA Consultancy Services LTD
Mumbai
10.2015 - 12.2019
  • Maintain complete understanding of Regulatory Information Management, Product Lifecycle Maintenance and activity specific guidance documents
  • Performing internal QC activities and supporting archival of documentation
  • Regulatory interact and co-ordinate with project manager/regional affiliate to ensure accuracy and completeness of data in system
  • Creation, Remediation and Updating of product Application, Events, PDS and Registration details in Regulatory information management system(Liquent Insight) for pharmaceutical, medical devices and consumer healthcare products
  • Updating API details, Excipients details, Packaging details, Shelf life and Storage conditions etc for the Products into repository by referring respective Dossiers and Regulatory Compliance File
  • Responsible for accurately remediating the existing legacy data, adding new entries and deleting entities within the system (if applicable) so that it is an authoritative source of product registration information which is readily available to the other key processes in Teva
  • Ensure Quality and TAT targets are achieved.

Education

M. Sc. (Biochemistry) -

S.I.E.S College - Mumbai University
01.2015

B. Sc. (Biochemistry/Biotechnology) -

S.I.E.S College - Mumbai University
01.2013

HSC -

Vani Vidyalaya
01.2010

SSC -

Vani Vidyalaya
01.2008

Skills

  • Team Leadership and Development
  • Well versed with Product Lifecycle Management
  • Analytical with strong background in understanding of ICH GCP and other regulatory
  • Good Communication, Proactive, Quick learner

Scholastic And Other Achievements

  • Lean certified, promoted and won many cheers awards in Genpact.
  • Awarded for best Performance by TCS twice.
  • Knowledge of Regulatory framework followed in different regions. Attended E0 Regulatory sessions.
  • Have good experience in working with team of 30 members on a project.

Personal Information

Date of Birth: 09/02/92

Marital Status : Married

Languages

  • English
  • Hindi
  • Kannada
  • Marathi

Affiliations

  • Dancing, Teaching dance, Reading, Drawing, Listening to music.

Disclaimer

I hereby declare that the above furnished information is true to the best of my knowledge.

Timeline

Lead Consultant - Regulatory Information Management System

Genpact India Pvt Ltd
08.2020 - Current

Regulatory Affairs Associate I - Regulatory Information Management System

TEVA Pharmaceutical
12.2019 - 07.2020

Senior Process Associate - RegulatoryInformation Management (Product Lifecycle Management)

TATA Consultancy Services LTD
10.2015 - 12.2019

M. Sc. (Biochemistry) -

S.I.E.S College - Mumbai University

B. Sc. (Biochemistry/Biotechnology) -

S.I.E.S College - Mumbai University

HSC -

Vani Vidyalaya

SSC -

Vani Vidyalaya

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