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Lifescience Regulatory Svs Associate

Accenture
Accenture
0-2 years
Not Disclosed
Bengaluru, India
10 May 11, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Overview

Field

Details

Job Title

LifeScience Regulatory Services Associate

Company

Accenture

Job ID

AIOC-S01634595

Location

Bengaluru

Employment Type

Full-Time

Experience Required

0–2 Years

Relevant Experience Mentioned

1–3 Years

Qualification Required

Bachelor of Pharmacy (B.Pharm) / Master of Pharmacy (M.Pharm)

Language Requirement

English (International) – Proficient

Shift Requirement

Rotational Shifts may be required


About the Company

Accenture is a multinational professional services company specializing in:

  • Technology services

  • Digital transformation

  • Cloud solutions

  • Security

  • Consulting and operations

The company operates in more than 120 countries with over 775,000 employees worldwide.


Business Unit

Life Sciences R&D – Regulatory Services

The role is part of Accenture’s Life Sciences Research & Development division, supporting:

  • Clinical operations

  • Pharmacovigilance

  • Regulatory affairs

  • Patient service solutions

This division helps global biopharmaceutical companies improve patient outcomes and meet regulatory requirements.


Role Summary

The LifeScience Regulatory Services Associate will support regulatory operations and submission activities for global pharmaceutical applications by:

  • Coordinating regulatory documentation

  • Managing electronic submissions

  • Supporting lifecycle management activities

  • Assisting in compliance with global regulatory standards

The role focuses on ensuring accurate and timely regulatory filing support for pharmaceutical products.


Key Responsibilities

Regulatory Operations Support

  • Assist organizations in complying with:

    • Regulatory requirements

    • Industry laws and standards

  • Support preparation and submission of regulatory documents

Electronic Submission Management

  • Process and manage electronic submissions including:

    • Original application filings

    • Amendments

    • Annual reports

    • SPL submissions

    • Ad-promotional submissions

    • CMC (Chemistry, Manufacturing, and Controls) submissions

Lifecycle Management

  • Support product lifecycle management activities

  • Coordinate documentation required for global regulatory filings

Compliance & Documentation

  • Maintain accurate regulatory records and documentation

  • Stay updated on changing regulatory requirements

  • Support compliance audits and reporting activities


Required Qualifications

Educational Qualification

  • Bachelor of Pharmacy (B.Pharm)

  • Master of Pharmacy (M.Pharm)


Required Skills & Competencies

Technical & Domain Skills

  • Understanding of:

    • Regulatory affairs

    • Pharmaceutical regulatory operations

    • Electronic submission processes

    • Lifecycle management submissions

Communication Skills

  • Proficient English communication skills

  • Ability to coordinate with cross-functional teams

Workplace Competencies

  • Attention to detail

  • Organizational skills

  • Ability to follow compliance procedures

  • Adaptability and flexibility


Roles & Responsibilities

Responsibility Area

Details

Problem Solving

Resolve routine operational issues using established guidelines

Team Interaction

Coordinate mainly with team members and direct supervisor

Work Guidance

Receive detailed to moderate instructions

Work Structure

Work as an individual contributor within a focused scope

Decision Impact

Decisions mainly affect individual work

Shift Requirement

Rotational shifts may be required


Work Environment

  • Regulatory operations and compliance environment

  • Process-driven pharmaceutical support operations

  • Cross-functional collaboration with life sciences teams

  • Exposure to global pharmaceutical regulatory systems


Desired Candidate Profile

Ideal candidates should have:

  • Interest in regulatory affairs and pharmaceutical operations

  • Strong documentation and organizational skills

  • Attention to detail and accuracy

  • Ability to work under timelines

  • Good communication and coordination skills


Career Growth Opportunities

This role can lead to:

  • Regulatory Affairs Associate

  • Regulatory Operations Specialist

  • Submission Management Associate

  • Pharmacovigilance Associate

  • Clinical Regulatory Coordinator

  • Regulatory Compliance Analyst


Diversity & Inclusion

Accenture promotes:

  • Equal employment opportunity

  • Inclusive workplace culture

  • Diversity and belonging

  • Employee well-being and professional growth

Employment decisions are made without discrimination based on:

  • Race

  • Gender

  • Religion

  • Disability

  • Sexual orientation

  • Veteran status

  • Citizenship status

  • Other protected categories


Suitable For

This role is suitable for:

  • Pharmacy graduates interested in regulatory affairs

  • Candidates seeking careers in pharmaceutical operations

  • Entry-level professionals in life sciences and compliance

  • Individuals interested in global regulatory submission processes