Merck KGaA

Senior Analyst - Regulatory Submission Management

Posted On

March 11, 2025

Location

Bangalore, Karnataka

Experience Level

C - Professional (1-3 years)

Job Type

Full-time

Apply By

May 13, 2025

Job Description

Job Title: Senior Analyst – Regulatory Submission ManagementLocation: Electronic City, Bangalore Job Description:Regulatory Submission & Document Management Specialist responsible for handling regulatory submissions, quality checks, and document management processes in compliance with global health authority requirements. This role will involve working with eCTD format submissions, Veeva Vault RIM (Breeze), and eRDMS, ensuring accuracy, timely completion, and proper archival of regulatory records. The ideal candidate will have expertise in regulatory operations, document management, and technical support for regulatory systems. Key Responsibilities:Responsible for creating the submissions in eCTD format and Quality checks of the dossier for submission to various Health Authorities (Publishing) and creation of Submission Content Plan (SCP) for the submissions to various customers.Uploading, archival and maintenance of CMC documents and submissions records in Veeva Vault RIM.Record creation and maintenance for site registrations in eRDMS (Breeze)End to end records creation for various regulatory activities in Veeva Vault RIM.Creation and submission of KPI reports on a Quarterly basis for on-time registrations.Training of Veeva Vault for new users in global level and providing technical support to Subject Matter Experts.Create Health Authority queries for Pharma and Food Materials in RIM and track to closure.Data Correctness check in eRDMS through reporting and user support Qualifications:Education: Master’s degree or PhD in Pharma, Regulatory affairs, or a related field.Experience: 3 -6 years in regulatory affairs of registrations, publishing, renewals, QC, validations, regulatory submission processes in eCTD format. Experience in data management, compliance reporting, and regulatory records maintenance. Skills:Excellent communication and collaboration skills to work with cross-functional teams.Ability to provide training and technical support.Strong analytical and problem-solving skills for data verification and reporting. We are an equal opportunity employer that values workforce diversity. We want everyone to be able to bring their best self to work every day which is why equality and inclusion is at the forefront of all our activities. We are dedicated to a policy of non-discrimination in employment on any basis including race, caste, creed, color, religion, sex, age, disability, marital status, sexual orientation, and gender identity.

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