Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Timeline
Generic

SUTEJA TANAWADE

Mölndal

Summary

Dynamic regulatory professional with extensive experience at AstraZeneca, specializing in XEVMPD and IDMP submissions. Over 8 years of proven track record in ensuring RIMS compliance and enhancing efficiency through effective data stewardship and regulatory submissions and RIMS implementation. Strong leadership and communication skills, complemented by expertise in Veeva RIMS, SQL querying, KPI development and process authoring.

Overview

13
13
years of professional experience

Work History

EXPERIENCE MANAGER

DATA, AstraZeneca AB
08.2020 - Current
  • XEVMPD Submissions: Ensuring 100% on-time submissions for both development and authorized medicinal products, which enables CTA submission and EMA-led submissions (ESMP) and this ensured compliance with health authority legislations
  • IDMP Expertise: Maintaining up-to-date knowledge of all ISO-IDMP chapters and aligning AstraZeneca's roadmap with the EMA's implementation plan
  • RIMS Support: Assisting with RIMS implementation and addressed migration-related queries
  • Veeva collaboration: Actively engaging with Veeva releases by sharing updates across teams about upcoming features, identifying risks on RIMS, and planning mitigation strategies in advance
  • Data Stewardship: Acting as a data steward for medicinal products, pharmaceutical products, and labeling documents
  • EAF Leadership: Leading eAF pilot submission meetings with cross-functional teams for the NAP (National Authorization Procedure)
  • SPOR and IRIS Submissions: Managing submissions to the EMA for registering information on substances, organizations, referentials, products, and marketing status
  • Process Authoring: Authored and reviewed processes and regulatory information related to XEVMPD, IDMP, and SPOR
  • Expert in data governance, process optimization, and KPI development: executing SQL queries in the Snowflake system to review and compare data across different systems effectively.

CONSULTANT, SENIOR SPECIALIST

Randstad lifesciences
01.2020 - 07.2020
  • Effectively managed EMA inspection queries, ensuring regulatory compliance and mitigating potential issues
  • Coordinated timely completion of regulatory tasks, including MAA, license renewals, and variations, enhancing efficiency
  • Updated regulatory information in RIMS, facilitating timely drug delivery to patients
  • Aligned license information with EMA legislation, supporting IDMP, and avoiding additional costs for pharmacovigilance advice notes.

PROJECT MANAGER

Mylan Pharmaceuticals
Hyderabad
01.2015 - 11.2017
  • Expertly managed regulatory projects end-to-end, ensuring compliance with EU, US, Japan, and Brazil regulations
  • I oversaw Chemistry, Manufacturing, and Controls (CMC) activities regionally, leading to successful material approval and dossier coordination
  • Additionally, I enhanced planning and delivery processes by maintaining data consistency, contributing to the overall success of the projects and submissions to health authority
  • Reviewed KPIs and metrics to identify the risks and mitigate them.

Serum institute of India, Ltd
Pune
05.2012 - 06.2012
  • Oversaw dossier review and regulatory specifications at the Serum Institute of India, Ltd
  • Pune, ensuring compliance with global regulatory bodies and guidelines
  • Managed the review of dossiers, analytical validation reports, and batch manufacturing records
  • Demonstrated a strong understanding of API, finished product, and excipient specifications
  • Ensured compliance with standard testing procedures, stability study protocols, and regulatory requirements.

Education

Master of Pharmaceutical Sciences - Pharmaceutical Sciences

BITS Pilani
07.2015

Bachelor of Pharmacy - Pharmaceutical Medicine

SGRS College of Pharmacy
07.2013

B. Pharm -

Indian Pharmaceutical Association
01.2010

Bachelor - Pharmacy

GPAT

Skills

  • Certified XEVMPD submissions expert (Gateway, EVWEB)
  • RIMS implementation (Veeva, CARA, Angel)
  • IDMP implementation
  • Data stewardship
  • Regulatory submissions (SPOR, IRIS, ePI, and ESMP)
  • Process authoring
  • KPI development
  • EAF web-based submissions
  • RMS, PMS API Integration
  • Project management
  • Leadership and communication skills
  • Regulatory compliance
  • Data governance, Master/Reference data management
  • SQL querying and analysis
  • DAMA (Data management) Training
  • PMS UI access and review
  • Master and Reference data management

Accomplishments

  • EXtended eudravigilance medicinal product dictionary (XEVMPD) training course attended during 5th to 6th May 2022 held by DIA Europe
  • XEVMPD Certified since 6th May 2022
  • DAMA (Data Management) : Attended a full-week course on DAMA principles, covering areas such as reference data management, master data management, data quality, data governance, data security, data integration, and interoperability, as well as metadata management
  • Since year 2022, an active account holder of various EMA accounts, SPOR, PLM portal, IRIS, CTA
  • Year 2007, certified in Maharashtra State Certificate in Information Technology
  • Year 2011, certified in National Level Pharmacy Talent Search Examination for excellence in
  • Pharmacy

Languages

  • Marathi : First Language
  • English : C2
  • Proficient (C2)
  • Swedish : B2
  • Upper Intermediate (B2)
  • Hindi : C2

    • Timeline

    EXPERIENCE MANAGER

    DATA, AstraZeneca AB
    08.2020 - Current

    CONSULTANT, SENIOR SPECIALIST

    Randstad lifesciences
    01.2020 - 07.2020

    PROJECT MANAGER

    Mylan Pharmaceuticals
    01.2015 - 11.2017

    Serum institute of India, Ltd
    05.2012 - 06.2012

    Master of Pharmaceutical Sciences - Pharmaceutical Sciences

    BITS Pilani

    Bachelor of Pharmacy - Pharmaceutical Medicine

    SGRS College of Pharmacy

    B. Pharm -

    Indian Pharmaceutical Association

    Bachelor - Pharmacy

    GPAT

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