Summary
Overview
Work History
Education
Skills
Timeline
Generic
Deepika Jeevanandam

Deepika Jeevanandam

Regulatory Professional
Bangalore

Summary

Detail-oriented individual with exceptional communication and project management skills. Proven ability to handle multiple tasks effectively and efficiently in fast-paced environments. Recognized for taking proactive approach to identifying and addressing issues, with focus on optimizing processes and supporting team objectives.

Overview

8
8
years of professional experience
5
5
years of post-secondary education

Work History

Operation Centre of excellence, Affiliate

NovoNordisk GBS
01.2021 - Current
  • Strategic planning of NDA/initial submission to local health authority.
  • Strategic planning and execution of other life cycle activities of the product in a market.g: variations both Clinical and CMC, Question and answer, manufacturing site registration (especially GMP renewal), retentions, safety signals, PSUR's, renewals and deregistration.
  • Leads and/or gives to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
  • A vast experience in stakeholder management both internal (crossfunctional team) and external (handled distributor managed markets).
  • Fully proficient in working with portals (TMDA and ZAMRA)
  • Adding to all this I have excelled in Veeva (Vault RIM) system, I have gained experience from planning to executing the batch release in a market.
  • Identifies regulatory risks and proposes mitigations to the lead and cross-functional teams.

Short Term Assignment in RA Clinical

NovoNordisk GBS
01.2025 - 08.2025
  • My IDP (Individual development plan) was to build expertise in Regulatory Affairs clinical.
  • I had a window of opportunity which led me to Regulatory Affairs clinical vertical in Rare endocrine disorder.
  • I played a vital role in submission of non-replacement indications in EU and US market.
  • Worked with PSUR's and label updates.
  • Not only did this opportunity enhance my knowledge for endocrine disorder but also helped me understand the EMA and FDA regulations.

Regulatory Affairs, Publishing

NovoNordisk GBS
01.2018 - 01.2021
  • I was responsible for global publishing tasks in Regulatory (electronic and paper) as per CTD/eCTD/NeeS/National format.
  • Streamlined the process and integrated them in CITRIX environment, further was involved in pilot phase implementation Veeva platform.
  • Coordination with RA Product Portfolio, Line of Business Manager & project participant
  • Involved in the pilot phase of veeva in publishing.

Education

Master of Science - Biotechnology

Vellore Institute of Technology
01.2013 - 01.2018

Skills

Stakeholder management

Problem-solving

Flexible and adaptable

Veeva vault expert

Timeline

Short Term Assignment in RA Clinical

NovoNordisk GBS
01.2025 - 08.2025

Operation Centre of excellence, Affiliate

NovoNordisk GBS
01.2021 - Current

Regulatory Affairs, Publishing

NovoNordisk GBS
01.2018 - 01.2021

Master of Science - Biotechnology

Vellore Institute of Technology
01.2013 - 01.2018
Deepika JeevanandamRegulatory Professional