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
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