Merck KGaA

Senior Specialist - Regulatory Submission Management

Posted On

Feb. 27, 2025

Location

Bangalore, Karnataka

Experience Level

D - Professional (4-9 years)

Job Type

Full-time

Apply By

April 29, 2025

Job Description

Title: Senior Specialist – Regulatory Submission ManagementLocation: Bangalore – Electronic City Job Description:6- 8 Years of experience in Regulatory Submission Management3 Years of experience in Veeva Vault.Manage and execute planning, compilation and dispatch of submissions to Health Authorities during the application lifecycle.Create and update submission packages and Submission Content Plans for submissions to Health Authorities.Create and update records in Regulatory Information Management system and ensure submissions are documented properly including tracking of HA questions and documentation of approval and registration details in Veeva Vault RIM.Liaise and follow-up with R&D functions to provide required submission-relevant documents on time and in submission ready format.Perform quality checks, validate eCTD output, and submit eCTDs through supported HA gateway.Collaborate with submission management and publishing vendors, resolve or coordinate any queries, and perform spot checks on output.Functional oversight of vendors for submission management and publishing.Crisis intervention in case of vendor issues to avoid impact on quality or project timelines.Key contact for eCTD and Publishing expertise.Act as power-user for submission applications (Veeva Vault RIM).Author cover letter and application forms in close cooperation with the License Manager or Regulatory Lead.Monitor compliance with submission standards and submission process (internal & external).Manage and improve quality of submission standards and templates for submission-relevant documents ensuring compliance with HA requirements.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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