Silpa Jalagam
Bangalore
Summary
Experienced Regulatory Affairs professional with over 6.5 years across the industry Expertise in submission management, and data governance. Expertise in planning, compiling, and publishing eCTD and NeeS submissions across multiple regions. Hands-on experience in regulatory submissions such as annual reports, PSUR/PBRER, variations, renewals, information requests, YBPR, DSUR, and promotional materials, while ensuring quality, timeliness, and alignment with global health authority requirements. Served as a Regulatory Data Management Expert and Submission Coordinator, leading cross-functional collaboration with Regulatory Scientists, CMC, and Labelling teams Contributing to significant process automation projects (e.g., ROSETTA PYRAMID, PromoMat Connector), mentoring junior staff, and enhancing system usability through structured archival solutions and SOP development.
Overview
6
6
years of professional experience
Work History
Regulatory Professional
Novo Nordisk
Bangalore
09.2023 - Current
- Independently publishing eCTD submissions for Europe (EMA) and GCC and other regional health authorities using Veeva Vault RIM and supporting Nees submissions.
- Maintaining incoming/outgoing correspondence logs and ensured full archival in Veeva Vault RIM and therefore creating HAQ records and commitments as per the correspondence type.
- Conducting QC of published applications to ensure compliance with regional specifications.
- Ensuring timely updates to product registrations in compliance with pharmaceutical regulatory requirements, to prevent disruptions in supply chain operations.
- Supporting Veeva Vault RIM improvement releases by doing testing and impact assessment for Application joins.
Global Regulatory Affairs Associate Manager (Submission Coordinator)
Eli Lilly
Bangalore
02.2019 - 09.2023
- Submission management support at the molecule/project level to ensure all required electronic records are timely, complete, and accurate for IND, NDA, BLA & NDS submissions.
- Submission management support for Advertising & Promotional Materials for marketed products.
- Served as a Regulatory Data Management Expert which includes uploading correspondence (Health authority communications) using Veeva Vault RIM for submission content plan.
- Supporting the team in timely planning the submission such as Developmental Safety Update Reports, NDA/BLA Annual Reports, Periodic Safety Update Report/Periodic Adverse Drug Experience Report, FDA RTQ’s and Advertisement and Promotional Materials using Veeva Vault RIM.
- Gained experience in Planning and Execution for electronic submission for US-FDA and Health Canada.
- Served as a Global Regulatory Affairs – North America operational lead for submission planning and execution includes chain planning sessions, status updates of documents, team operation meetings and GRA CRR planning.
- Partnered with different stakeholders to drive execution of the IND inactivation and withdrawal process.
- Partnered with Regulatory Scientist to plan, facilitate and document internal, FDA, and partner meetings.
- Contributed for the regulatory data management automation on ROSETTA PYRAMID which resulted in a decrease of task time by 85%, saving 65 hours a month per employee.
- Contributed to Advertising and Promotional Material submission planning automation in Veeva Vault RIM from Veeva Vault PromoMats (PromoMat Connector).
- Served as a Mentor and Subject Matter Expert for RIM data management and eTMF functional checks teams.
- Collaborated effectively with internal departments (Regulatory Scientists, Labelling & CMC teams) to plan the regulatory strategies, filing forecast for submissions to meet the business objectives of the organization.
- Performed Global Regulatory Affairs functional checks for clinical studies for the audit readiness in Vault Clinical.
- Contributed for building the archival system and HAQ database in RIM environment and creating Job Aids.
Education
M. Pharmacy - Pharmaceutical Regulatory Affairs
Manipal College of Pharmaceutical Sciences
Manipal, Karnataka01.2019
B.Pharmacy -
V.V. Institute of pharmaceutical sciences
JNTUK, Andhra Pradesh01.2017
Skills
- Veeva Vault RIM
- Global & Submission-Level Content Plan Management
- ECTD Publishing (Lorenz docubridge and eCTDXPress)
- Project & Stakeholder Management
- Health Authority Interactions & Correspondence
- Regulatory lifecycle management
- Submission management
Languages
- English
- Telugu
- Kannada
- Hindi
Languages
Telugu
First Language
English
Proficient (C2)
C2
Hindi
Upper Intermediate (B2)
B2
Timeline
Regulatory Professional
Novo Nordisk
09.2023 - Current
Global Regulatory Affairs Associate Manager (Submission Coordinator)
Eli Lilly
02.2019 - 09.2023
M. Pharmacy - Pharmaceutical Regulatory Affairs
Manipal College of Pharmaceutical Sciences
B.Pharmacy -
V.V. Institute of pharmaceutical sciences
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