Job Title: Life Sciences Regulatory Services Associate
Job Code: AIOC-S01612285
Employment Type: Full-Time
Experience Required: 0–2 Years
Location: Bengaluru
Qualification: B.Pharm / M.Pharm
About the Company
Accenture is a global professional services organization with expertise in Digital, Cloud, and Security solutions. With more than 699,000+ employees across 120+ countries, Accenture delivers consulting, technology, and operational services to clients worldwide.
Business Vertical
Life Sciences R&D
This vertical supports the global biopharma industry across:
Research and Development
Clinical Trial Operations
Regulatory Affairs
Pharmacovigilance
Patient Support Programs
You will work within the Regulatory Services function — enabling pharmaceutical companies to submit and maintain regulatory documentation in compliance with global health authority standards.
Role Overview
As a Regulatory Operations Associate, you will support the preparation and management of regulatory submissions, ensuring compliance with international regulatory guidelines (e.g., ICH). You will assist in document formatting, electronic submission activities, and quality checks.
Key Responsibilities
Perform bookmarking and hyperlinking for regulatory submission documents.
Review and transform source documents into submission-ready format.
Conduct Document Quality Control (QC) as per regulatory and compliance standards.
Assist in preparing regulatory submission components for:
Original Application Filings
Lifecycle Management (LCM) submissions (e.g., CMC updates, amendments, annual reports)
Ad-Promo submissions
Structured Product Labeling (SPL) submissions
Coordinate required documentation and resources for global regulatory filings.
Work with electronic document submission systems for compiling regulatory dossiers.
Skills & Attributes Required
|
Skill |
Description |
|---|---|
|
Quick Learning Ability |
Ability to understand regulatory processes fast |
|
Problem Solving |
Identify document issues and resolve formatting discrepancies |
|
Adaptability |
Ability to adjust to shifting project timelines |
|
Work Under Pressure |
Comfortable working in submission deadline environments |
|
Quality Focus |
Strong attention to detail and accuracy |
Work Model
Individual contributor role within a structured team environment
Daily guidance provided; detailed guidance given for new tasks
May require rotational work shifts
Equal Opportunity Statement
Accenture is an equal opportunity employer. Employment decisions are made without regard to gender, age, ethnicity, disability, religion, nationality, or other protected categories.
Important Notice
Accenture never asks for any payment at any stage of the hiring process. If you receive any request for payment, report it immediately to: india.fc.check@accenture.com
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