Regulatory Affairs (Veeva-Vault RIM)

vueverse.; Bengaluru; On-site; INR 800,000 - 1,200,000; Full time

Job summary

A leading technology consulting firm in Bengaluru seeks a detail-oriented RA-CMC Associate to support end-to-end regulatory submissions for global markets. Responsibilities include preparing variation documents, managing Lifecycle Management activities, and utilizing Veeva Vault RIM. The ideal candidate has over 3 years of experience in regulatory submissions with a strong understanding of ICH and global guidelines.

Qualifications

• 3+ years of experience in managing submissions and variations for global markets.
• Proficient in ICH guidelines and regulatory guidelines for multiple regions.
• Must have experience with Veeva Vault RIM.

Responsibilities

• Prepare Variation documents and evaluate post-approval CMC changes.
• Contribute to Lifecycle Management activities for compiling dossiers.
• Manage submission of variations/supplements for global markets.

Skills

Lifecycle Management (LCM)

Veeva Vault RIM

ICH guidelines

Job description

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We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets. Required exposure includes Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.

Responsibilities

• Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
• Contribute to Lifecycle Management (LCM) activities by helping to compile and review CTD dossier modules.
• Compile initial dossiers (Modules 2 & 3) for US / EU / SA / WHO / ANZ / Other Countries.
• Provide regulatory strategies and conduct evaluations of post-approval CMC changes considering ICH and country-specific guidelines.
• Manage compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries.
• Utilize Veeva Vault RIM to track queries and manage submission workflows.
• Review technical documents from manufacturing sites, including:
• Specifications
• Batch Manufacturing Records
• Process & Analytical Validations
• Batch Analysis Data
• Stability Data

Experience Requirement

• 3+ years of experience in managing Initial submissions, Variations, and full LCM (Lifecycle management) deliverables for the global markets.
• Must have experience with Veeva Vault RIM
• Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ ANZ/Other countries.
• Review of technical documents from manufacturing sites like of Specifications, Batch Manufacturing Records, Validations, Batch analysis data, Stability etc. required for compilation of dossier sections/Variations.
• Hands on experience in initial dossier compilation for US/EU/SA/WHO/ ANZ/Other countries (Module 2 & 3).
• Experience in providing Regulatory strategies/ Evaluation by performing assessment of post approval CMC Changes considering global regulatory requirements.
• Compilation and submission of Variations/ supplements for US/EU/SA/WHO/ANZ/Other countries as per applicable regulatory guidelines.

Seniority level

• Associate

Employment type

• Full-time

Job function

• Information Technology

Industries

• IT Services and IT Consulting

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