Nallapu Sudarshini

Haleon RIMS Associate

Freyr, Hyderabad

• Working with the regulatory systems and matrix team (RIMS team)
• Working as abusiness administrator of Veeva Vault. I make the system user-friendly and handle the quires of various departments.
• In RIMS, working and change requests and different queries related to document metadata, updating, applications, product variants, product families, etc. for Geo-Expansion and renewal records.
• Handling many different issues related Veeva via common mailbox.
• I was involved in the medical device application migration of common EU countries (Med device clean-up). Where i migrated 100+EU country registrations under one common application.
• I am currently working on the LENC (Local entity name change) project, where we are changing the name of all sites worldwide from GSK consumer healthcare to Haleon consumer healthcare.
• Besides this, working on few other projects in this project, I am involved on making strategies and attending kick-off meetings with LOCs on.
• Involved in system Enhancement Activity; through this, we bring automations onto the system.
• Monitor system performance and ensure that performance and capability issues are resolved effectively

• Preparation/Review/Update of Product information text (SmPC, PIL, Labeling) for DCP/MRP/NP/CP submissions.
• CMC activities related to different formulation and review with the specific requirements for filing planning, execution and submission of Dossiers for Europe market for various procedures (National, DCP, MRP & line-Extension).
• Assessment of the Change Controls and associated technical dossiers.
• Document and track regulatory submissions and regulatory authority approvals.
• Ensure adherence and compliance with scientific quality regulatory guidelines of EMA/ICH.

• Compilation of dossiers in e-CTD and CTD formats and review with the specific requirements for filing planning, execution and submission of Dossiers for Europe market for various procedures (National, DCP, MRP & line-Extension).
• Handling of query responses of medicinal products i.e., Preparation of responses to the regulatory deficiencies raised from EU regulatory and coordinating with other departments and responding to the Deficiencies with in timeline.
• Hands on experience in handling post-ling changes related to CEP/DMF Life Cycle Management (Variations: Type IA, IIA in, IB, II, Article 5 recommendations and editorial changes) and tracking of EP monograph updates.
• To verify specification of excipients, active, finished product and packaging material and all required documents.
• To collect and verify all technical documents and information from various departments at the manufacturing site and R&D site.
• Reviewing manufacturing documents like MFC, BMR, BPR, process validation protocol/report, stability protocol/report, sampling protocol, process validation protocol, method validation reports, and product development report, COA, Excipient specification, GMP certificates, Stability data and QOS.
• Evaluating queries raised by Regulatory Authority and preparing responses for the same and sending to respective Agencies.
• Ensure adherence and compliance with scientific quality regulatory guidelines of EMA/ICH.

• During this internship period i prepared and submitted regulatory EU Initial filings.
• I was responsible for requesting the documents from the QA and reviewing them with the ICH guidelines.