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Lifescience Regulatory Svs Associate

0-2 years
Not Disclosed
10 Nov. 11, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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